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For prostate cancer patients who experience biochemical progression during androgen deprivation therapy (ADT), prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) has not been prospectively compared to planar bone scan plus CT. This was a single-arm, head-to-head, prospective phase II trial (NCT04928820) designed to enroll 102 men with prostate cancer who experienced biochemical progression (rising prostate-specific antigen [PSA] ≥ 1 ng/mL) during ADT. All patients received 68Ga-PSMA-11 PET/CT and 99mTc-MDP planar bone scans. Each scan was interpreted by three central independent readers. The primary endpoint was the per-patient bone metastasis detection rate of PSMA PET/CT versus planar bone scan and CT. Secondary endpoints compared the number of bone metastases detected per patient and the inter-reader agreement of each imaging modality. Twenty-two men were enrolled between July 2021 and June 2022. Due to slow accrual following approval of PSMA PET radiotracers in the U.S. and a lack of a statistical signal between the two imaging modalities on interim analysis, this trial was closed early on October 2022. Median PSA was 8.5 ng/mL (interquartile range: 1.6-77.6). There was 100% agreement between the two scans. Six patients (27%) had negative findings and 16 patients (73%) had positive findings on both scans. PSMA PET/CT and bone scan plus CT detected an equal number of bone lesions for 14 patients (64%), PSMA PET/CT detected more bone lesions for six patients (27%), and bone scan plus CT detected more bone lesions for two patients (9.1%) (p = 0.092). The inter-reader agreement rates of PSMA PET/CT and bone scan plus CT were 96% and 82%, respectively (p = 0.25). In men with biochemical progression during ADT, 68Ga-PSMA-11 PET/CT and 99mTc-MDP planar bone scan plus CT had identical bone metastasis detection rates. Bone scan plus CT can continue to serve as a cost-effective and readily accessible restaging modality in patients with biochemical progression. ClinicalTrials.gov NCT04928820. Registered 16/06/2021.

Deciphering the genetic basis of prostate-specific antigen (PSA) levels may improve their utility for prostate cancer (PCa) screening. Using genome-wide association study (GWAS) summary statistics from 95,768 PCa-free men, we conducted a transcriptome-wide association study (TWAS) to examine impacts of genetically predicted gene expression on PSA. Analyses identified 41 statistically significant (p 0.5: CCNA2 and HIST1H2BN. Six of the 20 identified genes are not known to impact PCa risk. Fine-mapping based on whole blood and prostate tissue revealed five protein-coding genes with evidence of causal relationships with PSA levels. Of these five genes, four exhibited evidence of colocalization and one was conditionally independent of previous GWAS findings. These results yield hypotheses that should be further explored to improve understanding of genetic factors underlying PSA levels.

Nearly all men with metastatic hormone-sensitive prostate cancer treated with intermittent androgen deprivation therapy (ADT) experience recurrence within 6 mo of testosterone recovery. We conducted a single-arm phase 2 trial to evaluate whether addition of dual androgen receptor pathway inhibitors (ARPIs) and metastasis-directed stereotactic body radiotherapy (SBRT) to intermittent ADT improves recurrence rates for men with between one and five nonvisceral, extrapelvic metastases on prostate-specific membrane antigen positron emission tomography/computed tomography after prior radical prostatectomy. Patients received 6 mo of androgen annihilation therapy (AAT; leuprolide, abiraterone acetate plus prednisone, and apalutamide) and metastasis-directed SBRT. The primary endpoint was the percentage of patients with prostate-specific antigen (PSA)

BACKGROUND: Nearly one-third of patients with prostate cancer (PCa) experience biochemical recurrence (BCR) after primary definitive treatment. BCR increases the risk of distant metastasis and mortality in patients with prognostically unfavorable features. These patients are best managed with a tailored treatment strategy incorporating risk stratification using clinicopathological factors, next-generation imaging, and genomic testing. OBJECTIVE: This narrative review examines the utility of risk stratification for the management of patients with BCR in the context of clinical trial data, referencing the latest recommendations by European and US medical societies. METHODS: PubMed was searched for relevant studies published through May 21 2023 on treatment of patients with BCR after radical prostatectomy (RP) or external beam radiotherapy (EBRT). RESULTS: European and US guidelines support the risk-stratified management of BCR. Post-RP, salvage EBRT (with or without androgen deprivation therapy [ADT]) is an accepted treatment option for patients with BCR. Post-EBRT, local salvage therapies (RP, cryotherapy, high-intensity focused ultrasound, stereotactic body radiotherapy, and low-dose-rate and high-dose-rate brachytherapy) have demonstrated comparable relapse-free survival rates but differing adverse event profiles, short and long term. Local salvage therapies should be used for local-only relapses while ADT should be considered for regional or distant relapses. In practice, patients often receive ADT, with varying guidance for intermittent ADT vs. continuous ADT, due to consideration of quality-of-life effects. CONCLUSIONS: Despite a lack of consensus for BCR treatment among guideline associations and medical societies, risk stratification of patients is essential for personalized treatment approaches, as it allows for an informed selection of therapeutic strategies and estimation of adverse events. In lower-risk disease, observation is recommended while in higher-risk disease, after failed repeat local therapy, ADT and/or clinical trial enrollment may be appropriate. Results from ongoing clinical studies of patients with BCR should provide consensus for management.

BACKGROUND: Biochemical recurrence (BCR) following primary interventional treatment occurs in approximately one-third of patients with prostate cancer (PCa). Next-generation imaging (NGI) can identify local and metastatic recurrence with greater sensitivity than conventional imaging, potentially allowing for more effective interventions. This narrative review examines the current clinical evidence on the utility of NGI for patients with BCR. METHODS: A search of PubMed was conducted to identify relevant publications on NGI applied to BCR. Given other relevant recent reviews on the topic, this review focused on papers published between January 2018 to May 2023. RESULTS: NGI technologies, including positron emission tomography (PET) radiotracers and multiparametric magnetic resonance imaging, have demonstrated increased sensitivity and selectivity for diagnosing BCR at prostate-specific antigen (PSA) concentrations

We report our initial real-world experience with 177Lu-PSMA-617 radioligand therapy. Methods: We performed a retrospective review of patients treated with 177Lu-PSMA-617. Pretreatment PSMA PET, laboratory findings, overall survival, a fall in prostate-specific antigen by 50% (PSA50), and toxicities were evaluated. Results: Ninety-nine patients were included. Sixty patients achieved a PSA50. Seven of 18 (39%) patients who did not meet the TheraP PSMA imaging criteria achieved a PSA50. Nineteen of 31 (61%) patients who did not meet the VISION laboratory criteria achieved a PSA50. Sixty-three patients had a delay or stoppage in therapy, which was due to a good response in 19 patients and progressive disease in 14 patients. Of 10 patients with a good response who restarted treatment, 9 subsequently achieved a PSA50 on retreatment. The most common toxicities were anemia (33%) and thrombocytopenia (21%). Conclusion: At our center, patients who did not meet the TheraP PSMA imaging criteria or the VISION laboratory criteria benefited from 177Lu-PSMA-617 radioligand therapy.

Opinion statementPSMA-PET has been a practice-changing imaging biomarker for the management of men with PCa. Research suggests improved accuracy over conventional imaging and other PET radiotracers in many contexts. With multiple approved PSMA-targeting radiotracers, PSMA PET will become even more available in clinical practice. Its increased use requires an understanding of the prospective data available and caution when extrapolating from prior trial data that utilized other imaging modalities. Future trials leveraging PSMA PET for treatment optimization and management decision-making will ultimately drive its clinical utility.

PURPOSE: To assess the diagnostic performance and utility of the ExoDx IntelliScore and an OPKO4K score to predict prostate cancer in men presenting with elevated PSA-both as independent predictors and in combination with clinical/MRI characteristics. METHODS: Patients with elevated PSA were retrospectively reviewed. Abnormal tests were defined as an OPKO4K score ≥ 7.5% and an ExoDx IntelliScore ≥ 15.6. Four regression models and ROC curves were generated based on: (1) age, PSA, and DRE, (2) model 1 + OPKO4K 4Kscore ≥ 7.5%, (3) model 2 + ExoDx IntelliScore ≥ 15.6, and (4) model 3 + MRI PIRADS 4-5. RESULTS: 359 men received an OPKO4K test, 307 had MRI and 113 had ExoDx tests. 163 men proceeded to prostate biopsy and 196 (55%) were saved from biopsy. Mean age was 65.0 ± 8.7 years and mean PSA was 7.1 ± 6.1 ng/mL. Positive biopsies were found in 84 (51.5%) men. The sensitivity and negative predictive value of an OPKO4K score were 86.7% and 72.3%; values for an ExoDx test were 76.5% and 77.1%, respectively. On regression analysis, clinical markers (Age, PSA, DRE) generated an AUC of 0.559. The addition of an OPKO4K score raised the AUC to 0.653. The stepwise addition of an ExoDx score raised the AUC to 0.766. The combined use of both biomarkers, patient characteristics, and MRI yielded an AUC of 0.825. CONCLUSION: This analysis demonstrates the high negative predictive value of both the OPKO4K score and ExoDX IntelliScore independently while demonstrating that the combination of an OPKO4K score, an ExoDX IntelliScore, and MRI increases predictive capability for biopsy confirmed prostate cancer.

Distinguishing indolent from clinically significant localized prostate cancer is a major clinical challenge and influences clinical decision-making between treatment and active surveillance. The development of novel predictive biomarkers will help with risk stratification, and clinical decision-making, leading to a decrease in over or under-treatment of patients with prostate cancer. Here, we report that Trop2 is a prognostic tissue biomarker for clinically significant prostate cancer by utilizing the Canary Prostate Cancer Tissue Microarray (CPCTA) cohort composed of over 1100 patients from a multi-institutional study. We demonstrate that elevated Trop2 expression is correlated with worse clinical features including Gleason score, age, and pre-operative PSA levels. More importantly, we demonstrate that elevated Trop2 expression at radical prostatectomy predicts worse overall survival in men undergoing radical prostatectomy. Additionally, we detect shed Trop2 in urine from men with clinically significant prostate cancer. Our study identifies Trop2 as a novel tissue prognostic biomarker and a candidate non-invasive marker for prostate cancer.

Integrating isothermal nucleic acid amplification strategies into immunoassays can significantly decrease analytical limits of detection (LODs). On the other hand, an amplification step adds time, complication, reagents, and costs to the assay format. To evaluate the pros and cons in the context of heterogeneous multistep immunoassays, we quantified prostate-specific antigen (PSA) with and without rolling circle amplification (RCA). In addition, we compared time-gated (TG) with continuous-wave (CW) photoluminescence (PL) detection using a terbium complex and a fluorescein dye, respectively. For both direct (non-amplified) and amplified assays, TG PL detection provided circa four- to eightfold lower LODs, illustrating the importance of autofluorescence background suppression even for multi-wash assay formats. Amplified assays required an approximately 2.4 h longer assay time but led to almost 100-fold lower LODs down to 1.3 pg/mL of PSA. Implementation of TG-FRET (using a Tb-Cy5.5 donor–acceptor pair) into the RCA immunoassay resulted in a slightly higher LOD (3.0 pg/mL), but the ratiometric detection format provided important benefits, such as higher reproducibility, lower standard deviations, and multiplexing capability. Overall, our direct comparison demonstrated the importance of biological background suppression even in heterogeneous assays and the potential of using isothermal RCA for strongly decreasing analytical LODs, making such assays viable alternatives to conventional enzyme-linked immunosorbent assays (ELISAs). [ABSTRACT FROM AUTHOR]

Early diagnosis remains a major limitation of cancer outcomes with ethnicity and deprivation being determinants of inequalities that impact outcomes. Prostate cancer suffers from lower incidence rates and higher mortality rates in the most deprived versus the least deprived groups. We developed the 'Man Van' to enable high‐risk male patients' from deprived communities and ethnic minorities increased access to health care to address these health inequalities. Between December 2021 and December 2022 the Man Van project was piloted in eight different locations chosen using geospatial targeting based on ethnic minority populations and deprivation scores. The primary outcome measures were the prevalence of prostate cancer and other health conditions. 810 men were recruited to be seen at our Man Van clinics with 610 men attending. 48% of attendees were non‐White including 30% of men who were Black. 420 men had PSA tests performed with a median PSA of 1 μg/L. 15 prostate cancers were diagnosed (3.6%; 95% CI 2.0–5.9) with 10 of these being clinically significant disease. Black men were more likely to be diagnosed compared to white men: 7.1% versus 1.8% (p <.05). The Man Van project is a novel approach to tackling health inequalities combining awareness raising, improved access to healthcare as well as ease of follow‐up. Comparatively high levels of prostate cancers were diagnosed at early stages and high levels of other health conditions were found which could improve the economic value of the service. [ABSTRACT FROM AUTHOR]

Background: Direct evidence for the relationship between a large prostate (≥80 ml) and androgen receptor/PSA signal remains lacking in benign prostatic hyperplasia (BPH). Our aim is to identify whether the cause of a large prostate is related to progesterone receptor (PGR) androgen receptor (AR), oestrogen receptor α, β (ERα,β) and prostate-specific antigen (PSA). Materials and methods: Surgical specimens of BPH in plasmakinetic resection of the prostate (PKRP) with three groups of different prostate-sizes with mean volumes of 25.97 ml, 63.80 ml, and 122.37 ml were collected for immunohistochemical analysis of the tissue microarray with PGR, AR, PSA and ERs. Rats were castrated and treated with testosterone replacement to explore androgen and PGR, AR and ERs expression levels in the prostate. Quantitative real-time reverse transcription polymerase chain reaction (Rt-PCR) for mRNA detection of above genes was conducted. Results: Immunoblotting, Rt-PCR and immunohistochemistry assays showed that PGR, PSA, AR, ERα expression levels were positively correlated with prostate size and that ERβ expression levels were negatively correlated with prostate volume. Animal experiments have shown that prostate volume is decreased in castrated rats with decreased PGR, AR, ERα and increased ERβ expression levels. Conclusion: PGR, AR, ERs signals can be regarded as important factors for large-sized prostates in BPH patients (≥100 ml). [ABSTRACT FROM AUTHOR]

Purpose: to assess the utility of response monitoring to enzalutamide by using [68Ga]Ga-PSMA PET in mCRPC patients treated with enzalutamide as first-line therapy. Methods: patients underwent [68Ga]Ga-PSMA PET less than 8 weeks before and 3 months after starting enzalutamide. On the basis of EAU/EANM criteria, patients were categorized as PSMA responders (PET-R) or PSMA non-responders (PET-NR), whilst, based on PSA, they were classified as biochemical responders (PSA-R) or non-responders (PSA-NR). Survival analysis was performed using the Cox regression hazard model and the Kaplan-Meier method. Results: 69 patients were considered fully evaluable. We observed 47.8% of concordance between [68Ga]Ga-PSMA PET and PSA monitoring at 3 months after starting enzalutamide. For discordant cases, the PSA reduction has a weak impact on PFS and a significant impact on OS in PET-NR patients, whilst this change has no impact either for PFS and OS in PET-R ones. Conclusions: [68Ga]Ga-PSMA PET could be a useful imaging tool for monitoring response to enzalutamide in mCRPC patients, being more informative than PSA in this setting, and possibly better guiding clinicians in therapeutic decisions. [ABSTRACT FROM AUTHOR]

Background: Upfront androgen receptor signaling inhibitor (ARSI) along with androgen deprivation therapy is the current standard of care for metastatic castration-sensitive prostate cancer. However, evidence on second-line therapy after upfront ARSI is scarce. We aimed to evaluate the oncological outcome of ARSI versus docetaxel (DOC) after upfront ARSI therapy in a real-world clinical practice. Methods: Subjects were metastatic castration-resistant prostate cancer (mCRPC) patients who had progressed within 2 years of upfront ARSI therapy and received ARSI (ARSI group) or DOC (DOC group) as a second-line therapy. Second-line progression-free survival (second-line PFS), and second-line overall survival (second-line OS) were assessed. Propensity score matching (PSM) was used to adjust the clinicopathological features and treatment patterns. Results: A total of 101 mCRPC patients, 68 in the ARSI group, and 33 in the DOC group, were included in this analysis. Median second-line PFS was 6.3 months in the ARSI group and 4.9 months in the DOC group (p = 0.21). Median second-line OS was 25.0 months in the ARSI group and 14.2 months in the DOC group (p = 0.06). Prostate-specific antigen nadir ≤ 0.2 ng/ml during upfront ARSI therapy was significantly associated with improved second-line PFS. After PSM, no significant difference in second-line PFS and second-line OS were observed between the two groups. Conclusion: ARSI or DOC has comparable oncologic outcomes in terms of second-line PFS and second-line OS. Further prospective research with longer follow-ups will be needed to identify the optimal treatment after upfront ARSI therapy. [ABSTRACT FROM AUTHOR]

Objective: To assess the association between achievement of prostate‐specific antigen (PSA) levels ≤0.2 ng/mL (henceforth 'ultralow') and clinical outcomes in patients in the 'Targeted Investigational Treatment Analysis of Novel Anti‐androgen' (TITAN) study (ClinicalTrials.gov Identifier NCT02489318) with metastatic castration‐sensitive prostate cancer (mCSPC). Patients and Methods: Patients in the TITAN study with mCSPC were randomised to 240 mg/day apalutamide (n = 525) or placebo (n = 527) plus androgen‐deprivation therapy. This post hoc analysis assessed the achievement of a PSA level of 0.2–>0.02 ng/mL ('ultralow one' [UL1]) and ≤0.02 ng/mL ('ultralow two' [UL2]) vs >0.2 ng/mL with apalutamide treatment and its association with radiographic progression‐free survival (rPFS), overall survival (OS), time to castration‐resistant PC (TTCRPC), and time to PSA progression (TTPP). The landmark analysis and Kaplan–Meier methods were used. Results: By 3 months, more patients achieved UL1 and UL2 with apalutamide (38% and 23%) vs placebo (15% and 5%). In the apalutamide‐treated patients, UL2 vs PSA >0.2 ng/mL at landmark 3 months was associated with significantly longer rPFS (hazard ratio [HR] 0.28, 95% confidence interval [CI] 0.14–0.54), OS (HR 0.24, 95% CI 0.13–0.43), TTCRPC (HR 0.2, 95% CI 0.11–0.38), and TTPP (HR 0.11, 95% CI 0.04–0.27; nominal P values all <0.001); this association was also observed but less pronounced for UL1. Similar findings were observed at 6 months. Early onset of decline to UL2 by 3 months was associated with improved survival vs PSA >0.2 ng/mL anytime (HR 0.12, 95% CI 0.06–0.22; P < 0.001) in apalutamide‐treated patients. Conclusions: In this post hoc analysis of TITAN, patients with the deepest PSA decline derived the greatest benefit. These results extend our findings of apalutamide efficacy in the overall TITAN population, underscoring the clinical value of PSA kinetics as a marker for treatment efficacy. Patient Summary: Patients with metastatic prostate cancer that is sensitive to ongoing hormonal treatment benefited significantly from the addition of apalutamide compared with placebo. Those who achieved rapid and deep PSA reduction had the greatest survival benefit. [ABSTRACT FROM AUTHOR]

SABR-Dual is a phase-III trial with an initial phase-I safety cohort, of 2-fraction stereotactic radiotherapy (SABR) with optional magnetic resonance imaging (MRI)-based focal boost, using peri-rectal spacing, for localized prostate cancer. This represents the initial report from the phase-I non-randomized cohort. Subjects had favorable intermediate risk (FIR) or low risk prostate adenocarcinoma, and gland volume <80 cc. All underwent radiopaque hydrogel spacer and fiducial marker placement before simulation (computed tomography and 3-tesla T2 MRI). The clinical target volume included the entire prostate, and in FIR patients, 1-2 cm of seminal vesicle. A 2-mm expansion was applied for planning target volume (PTV), and a dose of 27 Gy was prescribed to the PTV-prostate, 23 Gy to the PTV-seminal vesicle, with an optional 30 Gy simultaneous boost to an MRI-defined dominant lesion. Primary endpoint was 3-month patient-reported changes in quality of life based on the Expanded Prostate Cancer Index Composite-26, International Prostate Symptom Score, and Sexual Health Inventory for Men questionnaires. Secondary endpoints were 6-month quality of life, acute toxicity (using Common Terminology Criteria for Adverse Events version 5.0) and early Prostate specific antigen (PSA) response. Among the 20 patients in the phase-I cohort, 95% had FIR disease, and 50% received a simultaneous boost. At median follow-up of 8 months, a 3-month minimally clinically important change occurred in 1/20 (5%), 6/20 (30%), 2/20 (10%), 4/20 (20%), and 5/20 (25%) in urinary incontinence, urinary obstructive, bowel, sexual, and hormonal domains. There was a mean increase of 1 ± 5.4 in International Prostate Symptom Score and decrease of 1.8 ± 6.5 in Sexual Health Inventory for Men scores. Rates of grade 2 urinary and bowel toxicity were 10% and 0%, respectively, with no grade ≥3 toxicities. Mean PSA decrease at last follow-up was 70.4% ± 17.7%. This generalizable protocol of 2-fraction prostate SABR using peri-rectal spacing is a safe approach for ultra-hypofractionated dose-escalation, with minimal acute toxicity. Longer-term outcomes and direct comparison with standard 5-fraction SABR are being studied in the phase-III randomized portion of SABR-Dual. [ABSTRACT FROM AUTHOR]

We aimed to determine if ultrahypofractionated proton therapy delivered via stereotactic body proton therapy (SBPT) is noninferior to conventionally fractionated proton therapy (CFPT) in patients with early prostate cancer. This study was a multicenter, randomized, controlled, noninferiority phase 3 trial that included patients with histologically confirmed low-risk prostate adenocarcinoma defined by Gleason score grouping 1, Prostate-specific antigen <10 ng/mL, and clinical stage T1-T2a N0 M0 according to 7th edition of the American Joint Committee on Cancer tumor-node-metastasis cancer staging system. Eligible participants were randomly assigned initially at a 1:1 ratio and later at a 2:1 ratio to SBPT (38 Gy in 5 fractions) or CFPT (79.2 Gy in 44 fractions). The primary endpoint was freedom from failure (FFF) at 2 years from the date of randomization. Noninferiority for FFF was determined based on 1-sided confidence intervals. Toxicities were compared at different time points using Fisher's exact test. Health-related quality-of-life (HRQoL) was analyzed at different time points using a mixed-effects linear model. This trial is registered with ClinicalTrials.gov, NCT01230866, and is closed to accrual. Between December 10, 2010, and September 29, 2020, 144 patients were enrolled and 135 were randomly assigned (90 to the SBPT group and 45 to the CFPT group). The median follow-up was 5 years (IQR, 3.9-5.2). The 2-year FFF was 100% for both groups, with the 1-sided 5-year risk difference in FFF between groups reported as 2.63% (90% CI, −1.70% to 6.96%), favoring the SBRT arm, thus fulfilling the prespecified criteria for noninferiority of SBPT compared with CFPT. Rates of gastrointestinal and genitourinary G2 and G3 toxicities did not differ significantly between groups. Further, HRQoL metrics did not differ significantly between groups over the study's median follow-up. SBPT is noninferior to CFPT regarding FFF, with similar long-term genitourinary and gastrointestinal toxicity rates and minimal impact in patient-reported HRQoL over time. [ABSTRACT FROM AUTHOR]

PURPOSE: Androgen receptor splice variant 7 (ARV-7) is a resistance mechanism to hormonal therapy in metastatic castrate-resistant prostate cancer (mCRPC). It has been associated with poor outcomes. On progression to castrate resistance, ARV-7 positivity has been identified in global populations at an incidence of 17.8%-28.8%. Here, we characterize the incidence of ARV-7 positivity in Asian patients with mCRPC in a prospective fashion and evaluate its implications on treatment outcomes. METHODS: Patients with mCRPC from multiple centers in Southeast and East Asia were enrolled in a prospective manner before initiation of androgen receptor signaling inhibitors or docetaxel. ARV-7 status was evaluated at baseline with three commercially available assays: AdnaTest Prostate Cancer platform, Clearbridge method, and IBN method. Clinical outcomes at progression were assessed. The primary end point of this study was prevalence of ARV-7 positivity; secondary end points were incidence of ARV-7 positivity, prostate specific antigen (PSA) response rate, PSA progression-free survival (PFS), and overall survival (OS). RESULTS: A total of 102 patients with a median age of 72 years at enrollment participated. Overall, an incidence of ARV-7 positivity of between 14.3% and 33.7% in Asian patients with mCRPC was demonstrated depending on the assay used. Patients found to have ARV-7 positivity at enrollment had a numerically worse PSA PFS compared with ARV-7 negative patients. CONCLUSION: In this study, the incidence of ARV-7 positivity in Asian patients with mCRPC was shown to be similar to the global population. Patients with ARV-7 positivity appear to have more aggressive disease with numerically worse PSA PFS and OS. Further prospective studies are needed to fully characterize the relationship that ARV-7 positivity has on prognosis of Asian patients with mCRPC. [ABSTRACT FROM AUTHOR]

PURPOSE: Few studies have explored the potential for pharmacological interventions to delay disease progression in patients undergoing active surveillance (AS). This preplanned transcriptomic analysis of patient samples from the ENACT trial aims to identify biomarkers in patients on AS who are at increased risk for disease progression or who may derive the greatest benefit from enzalutamide treatment. PATIENTS AND METHODS: In the phase II ENACT (ClinicalTrials.gov identifier: NCT02799745) trial, patients on AS were randomly assigned 1:1 to 160 mg orally once daily enzalutamide monotherapy or continued AS for 1 year. Transcriptional analyses were conducted on biopsies collected at trial screening, year 1, and year 2. Three gene expression signatures were evaluated in samples collected at screening and in available samples from patients on AS at any time during surveillance (expanded cohort): Decipher genomic classifier, androgen receptor activity (AR-A) score, and Prediction Analysis of Microarray 50 (PAM50) cell subtype signature. RESULTS: The Decipher genomic classifier score was prognostic; higher scores were associated with disease progression in the expanded cohort and AS arm of the expanded cohort. Patients with higher Decipher scores had greater positive treatment effect from enzalutamide as measured by time to secondary rise in prostate-specific antigen >25% above baseline. In patients treated with enzalutamide, higher AR-A scores and PAM50 luminal subtypes were associated with a greater likelihood of negative biopsy incidence at year 2. CONCLUSION: This analysis suggests that the Decipher genomic classifier may be prognostic for disease progression in AS patients with low- to intermediate-risk prostate cancer. Higher Decipher and AR-A scores, as well as PAM50 luminal subtypes, may also serve as biomarkers for treatment response. Higher Decipher or AR-A score, or PAM50 luminal subtype, may predict greater response to enzalutamide. [ABSTRACT FROM AUTHOR]

PURPOSE: Radium-223 improves overall survival (OS) and reduces skeletal events in patients with bone metastatic castration-resistant prostate cancer (CRPC), but relevant biomarkers are lacking. We evaluated automated bone scan index (aBSI) and circulating tumor cell (CTC) analyses as potential biomarkers of prognosis and activity. PATIENTS AND METHODS: Patients with bone metastatic CRPC were enrolled on a prospective single-arm study of standard radium-223. 99mTc-MDP bone scan images at baseline, 2 months, and 6 months were quantitated using aBSI. CTCs at baseline, 1 month, and 2 months were enumerated and assessed for RNA expression of prostate cancer–specific genes using microfluidic enrichment followed by droplet digital polymerase chain reaction. RESULTS: The median OS was 21.3 months in 22 patients. Lower baseline aBSI and minimal change in aBSI (<+0.7) from baseline to 2 months were each associated with better OS (P =.00341 and P =.0139, respectively). The higher baseline CTC count of ≥5 CTC/7.5 mL was associated with worse OS (median, 10.1 v 32.9 months; P =.00568). CTCs declined at 2 months in four of 15 patients with detectable baseline CTCs. Among individual genes in CTCs, baseline expression of the splice variant AR-V7 was significantly associated with worse OS (hazard ratio, 5.20 [95% CI, 1.657 to 16.31]; P =.00195). Baseline detectable AR-V7 , higher aBSI, and CTC count ≥5 CTC/7.5 mL continued to have a significant independent negative impact on OS after controlling for prostate-specific antigen or alkaline phosphatase. CONCLUSION: Quantitative bone scan assessment with aBSI and CTC analyses are prognostic markers in patients treated with radium-223. AR-V7 expression in CTCs is a particularly promising prognostic biomarker and warrants validation in larger cohorts. [ABSTRACT FROM AUTHOR]

PURPOSE: No consensus about the effectiveness of prostate-specific antigen (PSA) screening exists among clinical guidelines, especially for the elderly. Randomized trials of PSA screening have yielded different results, partly because of variations in adherence, and it is unlikely that new trials will be conducted. Our objective was to estimate the effect of annual PSA screening on prostate cancer (PC) mortality in Medicare beneficiaries age 67-84 years. METHODS: This is a large-scale, population-based, observational study of two screening strategies: annual PSA screening and no screening. We used data from 537,599 US Medicare (2001-2008) beneficiaries age 67-84 years who had a good life expectancy, no previous PC, and no PSA test in the 2 years before baseline. We estimated the 8-year PC mortality and incidence, treatments for PC, and treatment complications of PSA screening. RESULTS: In men age 67-74 years, the estimated difference in 8-year risk of PC death between PSA screening and no screening was –2.3 (95% CI, –4.1 to –1.1) deaths per 1,000 men (a negative risk difference favors screening). Treatment complications were more frequent under PSA screening than under no screening. In men age 75-84 years, risk difference estimates were closer to zero. CONCLUSION: Our estimates suggest that under conventional statistical criteria, annual PSA screening for 8 years is highly compatible with reductions of PC mortality from four to one fewer PC deaths per 1,000 screened men age 67-74 years. As with any study using real-world data, the estimates could be affected by residual confounding. [ABSTRACT FROM AUTHOR]

PURPOSE: In a previous exploratory study, modeled early longitudinal prostate-specific antigen (PSA) kinetics observed within the 100-first treatment days with androgen deprivation therapy with or without docetaxel was associated with progression-free survival (PFS) and overall survival (OS) in patients with prostate cancer with rising PSA levels after primary local therapy. This prognostic value had to be confirmed in different settings. The objectives were to assess PSA kinetics modeling in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with chemotherapy in FIRSTANA trial and to investigate modeled PSA kinetic parameters prognostic/predictive value. MATERIALS AND METHODS: FIRSTANA phase III trial (ClinicalTrials.gov identifier: NCT01308567) assessed whether cabazitaxel is superior to docetaxel in terms of PFS/OS in patients with chemotherapy-naïve mCRPC. PSA longitudinal kinetics was assessed using the previous kinetic-pharmacodynamics model. Patient modeled ELIMination rate constant K (PSA.KELIM) was used to categorize favorable/unfavorable PSA declines (standardized PSA.KELIM < or ≥ 1.0 days–1) and further correlated with PFS/OS. RESULTS: In total, 1,050 of 1,168 enrolled patients were assessable for PSA.KELIM estimation. The median PSA.KELIM was 0.02 days–1. In univariate analyses, PSA.KELIM exhibited a significant prognostic value regarding survival: unfavorable versus favorable PSA.KELIM; median PFS, 3.6 months (95% CI, 3.0 to 4.2) versus 4.7 months (95% CI, 3.9 to 5.2), P =.002; median OS, 17.4 months (95% CI, 14.8 to 19.3) versus 28.4 months (95% CI, 26.7 to 31.6), P <.001. In multivariate analyses, PSA.KELIM was significant for PFS (hazard ratio [HR], 0.79 [95% CI, 0.67 to 0.93], P =.005) and OS (HR, 0.51 [95% CI, 0.44 to 0.60], P <.001), together with baseline radiological tumor progression and PSA doubling time. PSA.KELIM predictive value was not significant across treatment arms. CONCLUSION: This external validation study confirmed previous results about modeled PSA longitudinal kinetics prognostic value regarding PFS/OS in patients with mCRPC treated with taxanes. PSA.KELIM could be used to identify a subpopulation with poor prognosis, who may benefit from treatment intensification. [ABSTRACT FROM AUTHOR]

Objective: In 2018, the United States Preventive Services Task Force promoted shared decision making between healthcare provider and patient for men aged 55 to 69. This study aimed to analyze rates of prostate-specific antigen (PSA) testing across racial and ethnic groups following this new recommendation. Methods: A secondary analysis was conducted of the 2020–2021 Behavioral Risk Factor Surveillance System database to assess men aged 55 or older without a history of prostate cancer. We defined four race-ethnicity groups: non-Hispanic Whites (NHWs), non-Hispanic Blacks (NHBs), Hispanics, and Other. The primary outcome was the most recent PSA test (MRT), defined as the respondent's most recent PSA test occurring pre-2018 or post-2018 guidelines. Logistic regression adjusted for covariates including age, socioeconomic status factors, marital status, smoking history, and healthcare access factors. Results: In the age 55 to 69 study sample, NHW men had the greatest proportion of MRT post-2018 guidelines (n = 15,864, 72.5%). NHB men had the lowest percentage of MRT post-2018 guidelines (n = 965, 66.6%). With NHW as referent, the crude odds of the MRT post-2018 guidelines was 0.68 (95% confidence interval (CI) = 0.53–0.90) for NHB. The maximally adjusted odds ratio was 0.78 (0.59–1.02). Conclusions: We found that NHB aged 55 to 69 reported decreased rates of PSA testing after 2018 when compared to NHW. This was demonstrated on crude analysis but not after adjustment. Such findings suggest the influence of social determinants of health on preventative screening for at-risk populations. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the efficacy and safety of triptorelin after radical prostatectomy (RP) in patients with negative lymph nodes. Methods: PRIORITI (NCT01753297) was a prospective, open‐label, randomized, controlled, phase 4 study conducted in China and Russia. Patients with high‐risk (Gleason score ≥ 8 and/or pre‐RP prostate‐specific antigen [PSA] ≥ 20 ng/mL and/or primary tumor stage 3a) prostate adenocarcinoma without evidence of lymph node or distant metastases were randomized to receive triptorelin 11.25 mg at baseline (≤ 8 weeks after RP) and at 3 and 6 months, or active surveillance. The primary endpoint was biochemical relapse‐free survival (BRFS), defined as the time from randomization to biochemical relapse (BR; increased PSA > 0.2 ng/mL). Patients were monitored every 3 months for at least 36 months; the study ended when 61 BRs were observed. Results: The intention‐to‐treat population comprised 226 patients (mean [standard deviation] age, 65.3 [6.4] years), of whom 109 and 117 were randomized to triptorelin or surveillance, respectively. The median BRFS was not reached. The 25th percentile time to BRFS (95% confidence interval) was 39.1 (29.9–not estimated) months with triptorelin and 30.0 (18.6–42.1) months with surveillance (p = 0.16). There was evidence of a lower risk of BR with triptorelin versus surveillance but this was not statistically significant at the 5% level (p = 0.10). Chemical castration was maintained at month 9 in 93.9% of patients who had received triptorelin. Overall, triptorelin was well tolerated and had an acceptable safety profile. Conclusion: BRFS was observed to be longer with triptorelin than surveillance, but the difference was not statistically significant. Plain language summary: After a diagnosis of prostate cancer, one of the current treatments is surgical removal of the prostate and its cancer from the body. This is called radical prostatectomy. This may cure the person. Unfortunately, sometimes the tumor may have already spread into neighboring cells (lymph nodes). If this has happened, we know that giving people a chemical castration therapy to lower their levels of male sex hormones may reduce the risk of the cancer spreading further. This is achieved by giving people an androgen deprivation therapy (ADT), such as triptorelin (which is used in this study). What we do not yet know, and what we investigated in this study, is whether ADT can also benefit people who do not have signs that their cancer has already spread to the lymph nodes. Our study involved 226 men from China and Russia and investigated whether giving triptorelin for 9 months would lead to better outcomes compared with giving no additional treatment (active surveillance). All people in the study had radical prostatectomy but only half of them were given triptorelin in the following 8 weeks. The time frame of 8 weeks was used because this is the time needed to make sure that the surgery had gone well, and that no biological markers of cancer were still present in the person's blood (the marker is called prostate‐specific antigen [PSA]). High levels of PSA are a sign that the prostate cancer has returned. People were monitored for 3 years with regular checks of their castration status and levels of the cancer marker (PSA). At the end of the study, we saw that it took longer for PSA levels to increase for people who had taken triptorelin than it did for those who had not had additional treatment, but the difference was not statistically significant. There were no unexpected safety concerns seen among the people taking triptorelin. Our findings are promising but more studies are needed to confirm if starting triptorelin shortly after surgery can benefit this group of people who have had their prostate cancer treated by radical prostatectomy and have no signs that their cancer has spread to the lymph nodes. [Correction added on 31th July 2024, after first online publication: Plain language summary is added in this version.] [ABSTRACT FROM AUTHOR]

Objectives: To retrospectively investigate whether a case-by-case combination of the Prostate Imaging Reporting and Data System version 2.1 (PI-RADS) with the Likert score improves the diagnostic performance of mpMRI for clinically significant prostate cancer (csPCa), especially by reducing false-positives. Methods: One hundred men received mpMRI between January 2020 and April 2021, followed by prostate biopsy. Reader 1 (R1) and reader 2 (R2) (experience of > 3000 and < 200 mpMRI readings) independently reviewed mpMRIs with the PI-RADS version 2.1. After unveiling clinical information, they were free to add (or not) a Likert score to upgrade or downgrade or reinforce the level of suspicion of the PI-RADS category attributed to the index lesion or, rather, identify a new index lesion. We calculated sensitivity, specificity, and predictive values of R1/R2 in detecting csPCa when biopsying PI-RADS ≥ 3 index-lesions (strategy 1) versus PI-RADS ≥ 3 or Likert ≥ 3 index-lesions (strategy 2), with decision curve analysis to assess the net benefit. In strategy 2, the Likert score was considered dominant in determining biopsy decisions. Results: csPCa prevalence was 38%. R1/R2 used combined PI-RADS and Likert categorization in 28%/18% of examinations relying mainly on clinical features such as prostate specific antigen level and digital rectal examination than imaging findings. The specificity/positive predictive values were 66.1/63.1% for R1 (95%CI 52.9–77.6/54.5–70.9) and 50.0/51.6% (95%CI 37.0-63.0/35.5-72.4%) for R2 in the case of PI-RADS-based readings, and 74.2/69.2% for R1 (95%CI 61.5–84.5/59.4–77.5%) and 56.6/54.2% (95%CI 43.3-69.0/37.1-76.6%) for R2 in the case of combined PI-RADS/Likert readings. Sensitivity/negative predictive values were unaffected. Strategy 2 achieved greater net benefit as a trigger of biopsy for R1 only. Conclusion: Case-by-case combination of the PI-RADS version 2.1 with Likert score translated into a mild but measurable impact in reducing the false-positives of PI-RADS categorization, though greater net benefit in reducing unnecessary biopsies was found in the experienced reader only. [ABSTRACT FROM AUTHOR]

Community-based health events provide an opportunity to increase knowledge, awareness, and screening for acute and chronic diseases among individuals living in a socioeconomically diverse community. Because there are limited reports of such events, here we describe our ten-year experience of annual men's health fairs. This retrospective study of the Michigan Institute of Urology Foundation evaluated Men's Health Events held in Detroit, Michigan, from 2012 to 2021. Over 10 years, 11,129 men were screened and > 100,000 screenings were performed. The majority of the attendees were African-American men (61%), had a college degree (67%) or a high school diploma (26%), and had an annual income of <$35K (47%) or $35-60 K (30%). From 2012 to 2021, participants who saw a doctor in the past year rose from 62 to 70%; the median age of men rose from 52 to 58; their median testosterone levels increased from 353 ng/dL to 412 ng/dL, and men with concerning prostate-specific antigen values (≥ 4 ng/mL) doubled from 5% to 10%. Among participants, 59% had cholesterol levels of < 200 mg/dL, 28% of 200–240 mg/dL, and 13% of > 240 mg/dL; 7% had glucose levels of < 70 mg/dL, 68% of 70–105 mg/dL, and 25% of > 105 mg/dL ; 24% had ≥ 140 mmHg systolic and 18% had ≥ 90 mmHg diastolic blood pressure. Our findings suggest that community health events are successful at attracting and screening diverse community members. Such events should emphasize screening of high-risk individuals for acute and chronic diseases and promote other health-related behaviors. [ABSTRACT FROM AUTHOR]

Background: Prostate cancer (PCa) screening recommendations do not support prostate-specific antigen (PSA) screening for older men. Such screening often occurs, however. It is, therefore, important to understand how frequently and among which subgroups screening occurs, and the extent of distant stage PCa diagnoses among screened older men. Methods: Using the 2014–2016 linked Ohio Cancer Incidence Surveillance System (OCISS) and Medicare administrative database, we identified men 68 and older diagnosed with PCa and categorized their PSA testing in the three years preceding diagnosis as screening or diagnostic. We conducted multivariable logistic regression analysis to identify correlates of screening PSA and to determine whether screening PSA is independently associated with distant stage disease. Results: Our study population included 3034 patients (median age: 73 years). 62.1% of PCa patients underwent at least one screening-based PSA in the three years preceding diagnosis. Older age (75–84 years: aOR [95% CI]: 0.84 [0.71, 0.99], ≥ 85: aOR: 0.27 [0.19, 0.38]), and frailty (aOR: 0.51 [0.37, 0.71]) were associated with lower screening. Screening was associated with decreased odds of distant stage disease (aOR: 0.55 [0.42, 0.71]). However, older age (75–84 years: aOR: 2.43 [1.82, 3.25], ≥ 85: aOR: 10.57 [7.05, 15.85]), frailty (aOR: 5.00 [2.78, 9.31]), and being separated or divorced (aOR: 1.64 [1.01, 2.60]) were associated with increased distant stage PCa. Conclusion: PSA screening in older men is common, though providers appear to curtail PSA screening as age and frailty increase. Screened older men are diagnosed at earlier stages, but the harms of screening cannot be assessed. [ABSTRACT FROM AUTHOR]

Introduction: Given the significance of the association between anthropometric variables and disease outlook, alongside prostate-specific antigen levels and prostate volume preceding prostate cancer diagnosis, coupled with limited research in this domain, our current investigation endeavors to explore the correlation between prognosis and prostate-specific antigen levels, as well as prostate volume metrics, among adult men. Material and methods: This cross-sectional study was conducted in 2020 on adult male patients over 40 years old who had been referred to Imam Khomeini Hospital in Ahvaz, Iran for annual screening. Demographic factors along with prostate-specific antigen level and prostate volume were collected by the physician and the study evaluator to examine the relationship with disease prognosis from all patients. Results: By examining 180 adult men with a mean age of 58.61 ± 10.01 years; the results show that the mean prostate volume in the total study population was 40 ± 6.93 milliliters. Analytical analysis shows that body mass index has a direct but relatively weak significant relationship with prostate volume (r=0.155, p=0.038). This is while the patients' age showed a stronger and more direct significant relationship with volume (r=0.862, p<0.001) and prostatespecific antigen (r=0.403, p<0.001). On the other hand, the relationship between prostate volume and prostate-specific antigen of patients was reported as a strong direct significant relationship (r=0.314, p<0.001). This is while the relationship between body mass index and prostate-specific antigen in the community was weak and insignificant (r=0.135, p<0.072). Conclusion: The study results indicate that the patient's age is an important factor for screening in men for prostate examination and in men over 40 years old it is considered a valuable prognostic factor. Also, body mass index level can be used as a factor to control prostate volume in adult men. [ABSTRACT FROM AUTHOR]

Objective Results Conclusions To investigate the relationship between the prostate‐specific antigen (PSA) free‐to‐total ratio (FTR) and International Society of Urological Pathology Grade Group ≥2, clinically significant prostate cancer (csPCa) in men with a low PSA level (≤4 ng/mL).Patients and MethodsData were obtained from the Prostate Cancer Prevention Trial. Patients with a PSA level of ≤4 ng/mL and who received a biopsy within a year of this PSA measurement were included. Associations between FTR and csPCa were investigated with logistic regression, adjusting for age and PSA, a re‐scaled Brier score (index of predictive accuracy), and decision curve analysis.A total of 406 patients were analysed with 139 (34%) having csPCa and 204 (50%) having any grade PCa. For those with an FTR ≤0.15, 46% had csPCa, vs 22% for those with a ratio ≥0.20. In a regression model, the predicted probability of csPCa for a 60‐year‐old with a PSA of 3 ng/mL was 61% if the FTR was 0.05, falling to 18% if the FTR was 0.30. A clear negative relationship between increasing FTR and probability of csPCa was observed. A model containing FTR additional to PSA and age provides greater net benefit as per decision curve analysis and likely superior discrimination and calibration measured by a higher index of predictive accuracy.In middle‐aged men with a PSA level between 1.5 and 4 ng/mL but otherwise indicated for biopsy, a low FTR is associated with higher rates of csPCa. It should be utilised as an additional, readily available and inexpensive test to improve prediction of csPCa and aid in patient counselling. [ABSTRACT FROM AUTHOR]

Purpose: To assess active surveillance (AS) adherence for prostate cancer (PCa) in a "real-world" clinical practice. Materials and methods: We utilized our institutional database which was built by interrogating electronic medical records for all men who got diagnosed with PCa from 1995 to 2022. Our cohort included all patients aged < 76 years, with PCa Gleason Grade (GG) 1 or 2, ≤ cT2c, PSA ≤ 20 ng/ml at diagnosis, enrolled on AS, and with at least one biopsy after diagnosis. Patients were separated into two groups based on the monitoring intensity. Patients with at least 1 PSA/year and at least 1 biopsy every 4 years were categorized as adherent to guidelines. Univariable and Multivariable logistic regression analyses were used to examine the impact of covariates on non-adherence to guidelines. Competing risks cumulative incidence was used to depict prostate cancer-specific mortality (PCSM). Results: A total of 546 men met the inclusion criteria. Overall, 63 (11%) patients were adherent to guidelines (Group 1), while 483 (89%) were not (Group 2). Median PSAs/year and median biopsies/year were 2.3 (2.0-2.7) and 0.4 (0.3–0.6) for Group 1, and 1.2 (0.7–1.8) and 0.2 (0.1–0.2) for Group 2, respectively (both p < 0.0001). At multivariable analysis, Black men had a 2.20-fold higher risk of being in Group 2 than White men (p < 0.05). Patients with cT2 (OR:0.24, CI:0.11–0.52) and those with CCI ≥2 (OR:0.40, CCI:0.19–0.82) were less likely to be in Group 2, when compared to cT1 stage and CCI = 0, respectively (both p < 0.05). At 10 years, the cumulative incidence estimate of PCSM for the entire cohort was 2.1%. Conclusion: We found substantial deviations from AS monitoring guidelines, particularly in biopsy frequency, which did not seem to compromise PCSM in patients with stable PSA. Notably, our findings suggest that strict adherence to guidelines, especially in patients with cT2 at diagnosis, remains crucial. [ABSTRACT FROM AUTHOR]

A ratiometric electrochemiluminescence (ECL) aptamer-based sensing platform was fabricated for prostate-specific antigen (PSA) determination. Activated CdS nanocrystals/multi-walled carbon nanotubes (CdS/MCNTs) and luminol-Pt/PAMAM nanocomposites (L-Pt/PAMAM NCs) were synthesized and used as cathodic and anodic ECL emitters, respectively. Amino group–modified aptamers were assembled on carboxylated magnetic beads, followed by hybridization with probe DNA functionalized L-Pt/PAMAM NCs. In the presence of PSA, the aptamer would bind specifically to the target PSA, thereby releasing L-Pt/PAMAM NCs. After magnetic separation, the separated L-Pt/PAMAM NCs would hybridize with capture DNA on CdS/MCNTs coated on glassy carbon electrode. This binding would lead to a decrease in cathodic ECL signal of CdS/MCNTs, due to the efficient energy transfer from CdS/MCNTs to L-Pt/PAMAM NCs. Meanwhile, L-Pt/PAMAM brought the anodic ECL signal from luminol. With the increase of PSA concentration, the ECL emission from luminol increased and the ECL emission from CdS/MCNTs decreased. The ratio of ECL intensity of luminol at 0.55 V and CdS/MCNTs at − 1.25 V could be used to quantify the concentration of PSA. This method enables sensitive and reliable detection of PSA over a wide range from 0.05 to 200 ng mL−1, and the detection limit is 0.02 ng mL−1. [ABSTRACT FROM AUTHOR]

In this study, a novel aptasensor based on a transition metal oxide–modified pencil graphite electrode (PGE) was developed for the diagnosis of early-stage prostate cancer (PCa) via monitoring the prostate-specific antigen (PSA), which is the main biomarker for PCa. Single-use PGEs modified with pulsed deposited manganese oxide (MnOx) film were used to attach the amino-terminated aptamer specific to the PSA via carbodiimide chemistry. The designed aptasensor was placed in an electrochemical cell containing ferri/ferrocyanide ions as a redox probe to measure the charge transfer resistances (Rct) of the electrode surface by electrochemical impedance spectroscopy (EIS) to follow the response of each modification step. The effect of the medium pH on the ionic structure of the aptamer molecule according to its pI value and, thus, the reversing of the direction of the response (ΔRct) by the pH change was also discussed. The level of PSA secreted from PCa cells was investigated using impedimetric transduction. The specificity of the aptasensor was validated through selectivity studies against non-specific tumor markers like VEGF and different cancer cell lines including breast cancer and androgen-insensitive prostate cancer. The developed system showcases a label-free, fast, specific, and cost-effective approach for PSA detection, highlighting the importance of medium pH and the electrostatic environment on the aptamer's response. Our work emphasizes the potential for such aptasensors in clinical diagnostics and paves the way for further exploration into using transition metal oxides in biosensing applications. [ABSTRACT FROM AUTHOR]

Purpose: Current research has not extensively explored the correlation between Systemic Inflammatory Index (SII) and prostate-specific antibody (PSA) levels. This study aimed to investigate the relationship between the SII and PSA levels in American males aged > 40 years without prostate cancer. Methods: Data were obtained from the 2003–2010 National Health and Nutrition Examination Survey (NHANES). Patients without complete SII or PSA data were excluded. Multiple linear regression models were used to investigate the possibility of a linear association between the SII and PSA levels. Fitted smoothed curves and threshold effect analyses were used to characterize the nonlinear relationships. Results: The study included 5982 male participants over the age of 40 years from the United States. The average SII (mean ± standard deviation) was 562.78 ± 355.60. The mean value of PSA was 1.85 ± 3.24. The results showed that SII exhibited a positive correlation with PSA (β = 0.0005, 95% CI: (0.0002, 0.0007)), and an interaction test indicated that the effects of age, body mass index, hypertension, and diabetes were not significant for this positive correlation between SII and PSA (all P > 0.05). We discovered an inverted U-shaped connection between the SII and PSA with a turning point (K) of 1168.18 by using a two-segment linear regression model. To the left of the turning point, there was a positive connection between SII and PSA (β = 0.0009,95% CI: (0.0006, 0.0012); P < 0.0001). Conclusion: In the population of men over 40 years old without prostate cancer, SII and PSA exhibited a non-linear relationship. Specifically, there was a positive correlation between SII and PSA levels when the SII value was < 1168.18. [ABSTRACT FROM AUTHOR]

Background: Globally, prostate cancer is a common disease among men. However, limited epidemiological data exists regarding prostate cancer in Tanzania. Consequently, there is insufficient evidence to convince policymakers of the need to combat this health issue. The study aimed to assess the prevalence, trends and clinicopathological characteristics of prostate cancer in northern Tanzania. Methods: This cross-sectional study with chart review utilised data from the Kilimanjaro cancer registry, identifying all adult men diagnosed with cancer from January 2015- December 2021. The study recorded variables such as subject age, symptoms, Gleason score, prostate specific antigen (PSA) and metastatic statuses at presentation. Risk stratification followed American Society of Medical Oncology criteria, including low, intermediate and high-risk categories. The analysis was conducted using STATA version 17. Results: Over the study period, 5164 adult men were registered, with prostate cancer accounting for 1619(31.4%) and showing an increase trend in incidence. The mean age at presentation was 73.9(± 10.1) years, and the majority of study subjects were from Kilimanjaro region 1200(74.1%). After applying exclusion criteria, 714 subjects with histologically confirmed diagnoses of prostate cancer remained. Of these, 710(99.4%) were symptomatic at presentation, with lower urinary tract symptoms being the most common symptoms in 548(76.8%). The median PSA at presentation was 109(36.2–263) ng/mL with 349(51.1%) having a PSA of > 100ng/mL. Gleason group grades 4 and 5 accounted for 207(29.5%) and 219(31.2%), respectively. A total of 178(43.6%) subjects had metastatic disease at presentation. The treatment of choice for a large proportion of subject 440(94.6%) was androgen deprivation therapy. Conclusions: The burden of prostate cancer in northern Tanzania is high and the majority of subjects present with symptoms. A large proportion of subjects have metastatic disease at initial presentation, emphasizing the need for prostate cancer screening. [ABSTRACT FROM AUTHOR]

This study examined the comparability of venous and capillary blood samples with regard to routine chemistry analytes.Venous and capillary blood samples were collected from adult patients to assess comparability of alanine transaminase, albumin, alkaline phosphatase, apolipoprotein B, aspartate aminotransferase, total bilirubin, calcium, chloride, creatin kinase, creatinine, C-reactive protein, ferritin, folic acid, free T4, gamma glutamyltransferase, glucose, high density lipoprotein cholesterol, iron, lipase, lipoprotein a, magnesium, phosphate, postassium, prostate specific antigen, sodium, total cholesterol, total protein, transferrin, triglycerides, thyroid stimulating hormone, urate, urea, vitamin B12 and 25-hydroxyvitamin-D3. Furthermore, hemolysis-icterus-lipemia Index (HIL-Index) was measured for all samples. All measurements were performed using the Siemens Atellica® CH or IH Analyzer. Deming regression analysis and mean relative differences between venous and capillary measurements of each analyte were contrasted with the desirable total allowable error (TEa) and Clinical Laboratory Improvement Amendments (CLIA) 2024 proposed acceptance limits for proficiency testing.Deming regression and mean relative differences demonstrated excellent comparability between venous and capillary samples for most measured analytes.Capillary and venous samples showed comparable results for almost all studied chemistry analytes. Of the 33 studied analytes for which TEa criteria where available, 30 met TEa criteria. CLIA 2024 criteria where available for 29 of the studied analytes of which only glucose did not meet the criteria. In conclusion, capillary blood draw is a suitable alternative for venous blood sampling for measuring most of the investigated analytes. This benefits patients with fear of needles and might pave the way for remote self-sampling. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions Approximately 10%–20% of prostate cancers progress to metastatic and castration‐resistant forms (mCRPC). Radioligand (RLT) therapy with [177Lu]Lu‐prostate‐specific membrane antigen (PSMA) is an approved treatment for metastasized mCRPC. Moreover, Actinium‐225 (225Ac), an alpha‐emitter isotope, has also been used to label PSMA and, recently, to treat mCRPC patients with encouraging results. However, robust clinical data on [225Ac]Ac‐PSMA therapy and its comparison with [177Lu]Lu‐PSMA are still limited. Our aim was to evaluate the role of [225Ac]Ac‐PSMA in treating mCRPC and compare it with conventional [177Lu]Lu‐PSMA therapy.A systematic search was performed in PubMed, Web of Science, Scopus and the Cochrane Register of Controlled Trials from June 2023 to January 2024. This work was conducted in accordance with PRISMA guidelines.After screening and study selection according to PRISMA guidelines, 11 studies were included, 9 of which focused on [225Ac]Ac‐PSMA only and two on tandem therapy ([225Ac]Ac‐PSMA/[177Lu]Lu‐PSMA). Overall, the pooled proportion of PSA decline in patients was .85 (95% CI: .79–.91, p < .001); patients pretreated with [177Lu]Lu‐PSMA achieved a pooled proportion of PSA decline of .90 (95% CI: .82–.97, p < .001). In patients treated with tandem therapy, PSA decline was observed in approximately 90% of them, while PSA response rates above 50% ranged from 53.3% to 65%. Xerostomia was the most frequently reported side effect, along with anaemia, thrombocytopenia and nephrotoxicity.Overall, the main results of our study showed that [225Ac]Ac‐PSMA‐617 had a significant therapeutic effect on mCRPC with an acceptable toxicity level. The latter, however, appears greater than with [177Lu]Lu‐PSMA‐617. In future studies, an adequate analysis of the incidence of side effects associated with [225Ac]Ac‐PSMA should be performed to evaluate the role of cumulative toxicity of earlier treatments and the higher frailty of heavily pretreated patients. [ABSTRACT FROM AUTHOR]

Simple Summary: This study explores the association of two gene polymorphisms (AR (CAG)n and APEX1 c.444T>G (p.Asp148Glu)) with biochemical recurrence in Argentinian patients with prostate cancer. The findings suggest that patients with certain alleles (AR (CAG)M and the heterozygous APEX1 c.444TG genotype) are linked to an increased risk of prostate cancer relapse, even when accounting for conventional clinicopathological variables. Notably, patients with a combined AR (CAG)M and APEX1 c.444TT/GG genotype had the highest risk of relapse, indicating the potential of these polymorphisms as independent predictors. These results are particularly relevant for patients with prostate specific antigen (PSA) serum levels <10 ng/mL, where traditional markers may not predict outcomes. By incorporating these genetic markers into clinical models, this research offers a novel approach to enhance the precision of prostate cancer prognosis and improve patient stratification, ultimately guiding more personalized treatment strategies for high-risk individuals. Background/Objectives: Prostate cancer (PCa) is the leading malignancy and the third most common cause of cancer-related death in Argentinian men. Predicting outcomes in localized PCa remains difficult due to tumor heterogeneity. In this study, we assessed the impact of AR (CAG)n and APEX1 c.444T>G polymorphisms on biochemical relapse in Argentine patients with localized PCa. Methods: We genotyped blood samples from 123 PCa patients for AR (CAG)n and APEX1 p.Asp148Glu (c.444T>G) polymorphisms. Associations with clinicopathological parameters and biochemical relapse-free survival (BRFS) were assessed. Results: AR (CAG)20–23 was associated with a family history of breast/ovarian cancer (p = 0.0469). The combination of AR (CAG)20–23 and APEX1 c.444TT/GG correlated with a 2.89 times higher risk of biochemical relapse (log-rank p = 0.006). Multivariable analysis confirmed AR and APEX1 polymorphisms as independent predictors of biochemical relapse (HR = 3.95, p = 0.002). In patients with PSA levels <10 ng/mL, combined AR (CAG)20–23 and APEX1 c.444TT/GG genotypes were significantly associated with an increased risk of biochemical relapse (HR = 2.61, p = 0.044). Multivariable analysis confirmed the prognostic significance of these genotypes (HR = 3.44, p = 0.02). Conclusions: This study has identified AR (CAG)n and APEX1 c.444T>G polymorphisms as independent predictors of PCa relapse in Argentinian patients, suggesting their potential use in improving prognostic models. [ABSTRACT FROM AUTHOR]

AbstractBackgroundMethodResultsConclusionIn robot-assisted radical prostatectomy (RARP), the peritoneal edges isolate the extended pelvic lymph node dissection bed from the peritoneal cavity. We studied the effect of peritoneal re-configuration through peritoneal flap fixation (PFF) with curling technique on lymphocele development.We included 2087 patients who underwent RARP between 2010 and 2022. Two hundred and thirty patients whose operation was performed using the PFF with curling technique were matched in a 1:1 ratio with non-PFF patients based on age, body mass index, initial prostate-specific antigen, and number of removed lymph nodes. Demographic, clinical, intraoperative and postoperative characteristics were collected. Complications were classified using the Clavien-Dindo system and the presence of lymphocele was documented.The two groups were similar in respect to matching parameters. Fifteen (6.5%) patients in the non-PFF group and two (0.9%) patients in the PFF group suffered from symptomatic lymphocele with symptoms such as abdominal pain, fever, lower extremity and/or genital oedema (p = 0.001). Asymptomatic lymphocele was diagnosed by ultrasonography in 19 (8.3%) patients in the non-PFF group and eight (3.5%) patients in the PFF group (p = 0.029).The results of our study support this concept by providing solid indications of the clinical benefits and safety of PFF with the curling technique. [ABSTRACT FROM AUTHOR]

For men with intermediate-risk prostate cancer treated with definitive therapy, the addition of androgen deprivation therapy (ADT) reduces the risk of distant metastasis and cancer-related mortality. However, the absolute benefit of ADT varies by baseline cancer risk. Estimates of prognosis have improved over time, and little is known about ADT decision making in the modern era. We sought to characterize variability and identify factors associated with intended ADT use within the Michigan Radiation Oncology Quality Consoritum (MROQC). Patients with localized prostate cancer undergoing definitive radiation therapy were enrolled from June 9, 2020, to June 26, 2023 (n = 815). Prospective data were collected using standardized patient, physician, and physicist forms. Intended ADT use was prospectively defined and was the primary outcome. Associations with patient, tumor, and practice-related factors were tested with multivariable analyses. Random intercept modeling was used to estimate facility-level variability. Five hundred seventy patients across 26 facilities were enrolled with intermediate-risk disease. ADT was intended for 46% of men (n = 262/570), which differed by National Comprehensive Cancer Network favorable intermediate-risk (23.5%, n = 38/172) versus unfavorable intermediate-risk disease (56.3%, n = 224/398; P <.001). After adjusting for the statewide case mix, the predicted probability of intended ADT use varied significantly across facilities, ranging from 15.4% (95% CI, 5.4%-37.0%) to 71.7% (95% CI, 57.0%-82.9%), with P <.01. Multivariable analyses showed that grade group 3 (OR, 4.60 [3.20-6.67]), ≥50% positive cores (OR, 2.15 [1.43-3.25]), and prostate-specific antigen 10 to 20 (OR, 1.87 [1.24-2.84]) were associated with ADT use. Area under the curve was improved when incorporating MRI adverse features (0.76) or radiation treatment variables (0.76), but there remained significant facility-level heterogeneity in all models evaluated (P <.05). Within a state-wide consortium, there is substantial facility-level heterogeneity in intended ADT use for men with intermediate-risk prostate cancer. Future efforts are necessary to identify patients who will benefit most from ADT and to develop strategies to standardize appropriate use. [ABSTRACT FROM AUTHOR]

Background: Anabolic androgenic steroids (AAS) are synthetic forms of testosterone frequently used as performance enhancing drugs among gay, bisexual, and queer (GBQ) men. Despite widespread use, associated harms, and the likely existence of an AAS use disorder, there is no medical consensus on standards of care for people who use AAS, with most medical providers focusing exclusively on abstinence. Individuals using AAS have developed community-based harm reduction strategies to mitigate these harms. Methods: This paper is a sub-analysis of qualitative data obtained through semi-structured interviews with GBQ men using AAS for 8 or more weeks recruited through convenience and snowball sampling from clinical sites and LGBTQ + venues in New York City as well as through social media. Interviews were coded with themes developed using reflexive thematic analysis. Data related to harm reduction techniques were then re-analyzed through a prevention strategies framework lens of primary, secondary, and tertiary harm prevention. Results: Thematic saturation was reached at twelve interviews in the primary analysis, with men reporting frequent use of multiple harm reduction techniques. For primary prevention, men avoided oral steroids and simultaneous substance use, tried to obtain AAS from reputable sources, used "cycling" to dose steroids, and practiced sterile injection techniques. Secondary prevention methods included patient-directed lab testing for hematocrit, liver and kidney function, cholesterol, prostate specific antigen, testosterone, and self-performed blood pressure checks. Tertiary prevention included donating blood and the use of medications without a prescription, including aromatase inhibitors, selective estrogen receptor blockers, aspirin, statins, angiotensin receptor blockers, clomiphene, and human chorionic gonadotropin. Conclusions: Despite many GBQ men experiencing harms from anabolic androgenic steroids, community members have often sought harm reduction techniques in lieu of abstinence. Though many of these techniques embrace clinical reasoning and may be more broadly applicable, additional research is needed to understand the impact of each intervention on the overall health of individuals using AAS. [ABSTRACT FROM AUTHOR]

Primary seminal vesicle lymphoma is a remarkably rare condition, predominantly manifesting as diffuse large B-cell lymphoma. Due to its rarity and nonspecific clinical presentations, it is often misdiagnosed or overlooked. Here, we report a case of a 68-year-old male diagnosed with primary seminal vesicle lymphoma, coinciding with prostate cancer. The diagnosis followed initial findings of elevated prostate-specific antigen levels and abnormal magnetic resonance imaging of the prostate and left seminal vesicle. Suspicion of prostate cancer led to a radical resection of both the prostate and seminal vesicle. Subsequent pathological examination and next-generation sequencing post-surgery confirmed the diagnosis of primary seminal vesicle diffuse large B-cell lymphoma, characterized by CD79B mutation type (MCD type). The patient was treated with six cycles of the R-CHOP regimen (rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone), achieving complete metabolic remission as confirmed by positron emission tomography-computed tomography. Fifteen months post-treatment, the patient's condition remains favorable. Through our literature review of additional six cases of primary seminal vesicle lymphoma, we aim to elucidate the typical clinical presentations, imaging features, pathological characteristics, genetic mutations, and therapeutic strategies, aiming to contribute to better detection and management of this rare malignancy. This case underscores the diagnostic challenges and emphasizes the necessity for heightened clinical suspicion and definitive pathological examination in the management of primary seminal vesicle lymphoma. [ABSTRACT FROM AUTHOR]

Prostate cancer (PCa) is a major world-wide health concern. Current diagnostic methods involve Prostate-Specific Antigen (PSA) blood tests, biopsies, and Magnetic Resonance Imaging (MRI) to assess cancer aggressiveness and guide treatment decisions. MRI aligns with in silico medicine, as patient-specific image biomarkers can be obtained, contributing towards the development of digital twins for clinical practice. This work presents a novel framework to create a personalized PCa model by integrating clinical MRI data, such as the prostate and tumour geometry, the initial distribution of cells and the vasculature, so a full representation of the whole prostate is obtained. On top of the personalized model construction, our approach simulates and predicts temporal tumour growth in the prostate through the Finite Element Method, coupling the dynamics of tumour growth and the transport of oxygen, and incorporating cellular processes such as proliferation, differentiation, and apoptosis. In addition, our approach includes the simulation of the PSA dynamics, which allows to evaluate tumour growth through the PSA patient's levels. To obtain the model parameters, a multi-objective optimization process is performed to adjust the best parameters for two patients simultaneously. This framework is validated by means of data from four patients with several MRI follow-ups. The diagnosis MRI allows the model creation and initialization, while subsequent MRI-based data provide additional information to validate computational predictions. The model predicts prostate and tumour volumes growth, along with serum PSA levels. This work represents a preliminary step towards the creation of digital twins for PCa patients, providing personalized insights into tumour growth. [ABSTRACT FROM AUTHOR]

Objective: Rare disease Objective: Rare disease Background: One percent of paraneoplastic syndromes described in the literature present as cutaneous manifestations such as vasculitis, which may reveal potential initial diagnoses. Leukocytoclastic vasculitis is a subtype of small-vessel vasculitis. It affects the skin and internal organs, and diagnosis relies solely on histopathological examination. The literature on leukocytoclastic vasculitis linked with malignancies is scarce. Case Report: We present the case of a 60-year-old man with multiple cardiovascular comorbidities, presenting with dysuria and elevated prostate-specific antigen (PSA) levels. Further investigations led to diagnosis of metastatic prostate adenocarcinoma. Concurrently, he developed non-specific cutaneous lesions. He underwent hormonal therapy and radiotherapy. During initial treatment, the lesions rapidly progressed to necrotic ulcers; therefore, hormonal therapy was withheld. Extensive investigations ruled out potential infectious or rheumatological causes of the lesions, and histopathological analysis was consistent with cutaneous leukocytoclastic vasculitis. The patient underwent systemic corticoid treatment while continuing radiotherapy. Following completion of radiation therapy and a corticosteroid course, the patient showed good clinical response, with decreased PSA level, resolution of urological symptoms, and clinical improvement of the lesions. He was cleared for hormonal treatment continuation. Conclusions: Given the temporal relationship between the onset of vasculitis, its exacerbation during first days of cancer treatment initiation and the rapid resolution following radiotherapy, a paraneoplastic etiology for leukocytoclastic vasculitis can be considered in this case. While the literature on leukocytoclastic vasculitis associated with malignancies is limited, clinicians must maintain vigilance to ensure timely and accurate diagnosis. Background: One percent of paraneoplastic syndromes described in the literature present as cutaneous manifestations such as vasculitis, which may reveal potential initial diagnoses. Leukocytoclastic vasculitis is a subtype of small-vessel vasculitis. It affects the skin and internal organs, and diagnosis relies solely on histopathological examination. The literature on leukocytoclastic vasculitis linked with malignancies is scarce. Case Report: We present the case of a 60-year-old man with multiple cardiovascular comorbidities, presenting with dysuria and elevated prostate-specific antigen (PSA) levels. Further investigations led to diagnosis of metastatic prostate adenocarcinoma. Concurrently, he developed non-specific cutaneous lesions. He underwent hormonal therapy and radiotherapy. During initial treatment, the lesions rapidly progressed to necrotic ulcers; therefore, hormonal therapy was withheld. Extensive investigations ruled out potential infectious or rheumatological causes of the lesions, and histopathological analysis was consistent with cutaneous leukocytoclastic vasculitis. The patient underwent systemic corticoid treatment while continuing radiotherapy. Following completion of radiation therapy and a corticosteroid course, the patient showed good clinical response, with decreased PSA level, resolution of urological symptoms, and clinical improvement of the lesions. He was cleared for hormonal treatment continuation. Conclusions: Given the temporal relationship between the onset of vasculitis, its exacerbation during first days of cancer treatment initiation and the rapid resolution following radiotherapy, a paraneoplastic etiology for leukocytoclastic vasculitis can be considered in this case. While the literature on leukocytoclastic vasculitis associated with malignancies is limited, clinicians must maintain vigilance to ensure timely and accurate diagnosis. [ABSTRACT FROM AUTHOR]

Background: Increasing evidence suggests that serum urea nitrogen may be a risk factor for prostate cancer (PCa) and influence serum prostate-specific antigen (PSA) concentrations, but direct evidence of a relationship between PSA and serum urea nitrogen levels in the general population is still lacking. The aim of this study was to demonstrate the relationship between serum urea nitrogen levels and prostate-specific antigen (PSA) and prostate cancer. Methods: We conducted a cross-sectional study using the National Health and Nutrition Examination Survey (NHANES, 2003–2010) database. We performed a multifactorial regression analysis of the association between serum urea nitrogen levels and PSA and PCa, followed by subgroup analyses. Results: A total of 5256 subjects were included in this study, and after adjusting for demographic, biological, and immunologic variables, we found that there was a threshold for blood urea nitrogen concentration below which every 1 ng/mL increase in serum urea nitrogen was associated with a 0.0325 ng/mL increase in PSA concentration (log2 transformed) (95% CI: 0.0064, 0.0586), and the P trend was was less than 0.05 and the difference was statistically significant. Sensitivity analyses using the generalized additive model (GAM) showed a linear relationship between serum urea nitrogen and serum PSA concentrations when blood urea nitrogen concentrations ranged from 0 ng/ml to 6.78 ng/ml. Conclusion: Serum urea nitrogen was independently and positively correlated with serum PSA concentration when the concentration of serum urea nitrogen ranged from 0 ng/ml to 6.78 ng/ml. [ABSTRACT FROM AUTHOR]

Background: Androgen receptor signaling inhibitors (ARSis), when administered sequentially or in combination with docetaxel and androgen deprivation therapy (ADT), have been shown to enhance overall survival (OS) and progression-free survival (PFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Nonetheless, the optimal sequence for administering chemotherapy and ARSis remains to be determined. Objective: To compare the efficacy of ARSis sequential therapy with ARSis combined therapy for mHSPC, and to evaluate the efficacy and safety of different combination regimens. Methods: The PubMed, Embase, Cochrane Central, and ClinicalTrials.gov databases were searched from their inception through 14 July 2024, to identify eligible phase III randomized clinical trials (RCTs) evaluating the combination or sequential use of docetaxel + ADT with abiraterone, enzalutamide, apalutamide, or darolutamide. The outcomes of interest included OS, PFS, time to prostate-specific antigen (PSA) progression, grade 3–5 adverse events (AEs), and serious adverse events (SAEs). Results: Five RCTs involving 2836 patients were included in the analysis. When comparing ARSis sequential therapy to ARSis combined therapy, no significant differences were observed in OS (Hazard Ratio (HR): 1.17, 95% Confidence Interval (CI): 0.69–1.96), PFS (HR: 1.03, 95% CI: 0.47–2.22), or time to PSA progression (HR: 0.48, 95% CI: 0.03–7.69). Within the different ARSis combined regimens, the triple therapies involving enzalutamide, abiraterone, and darolutamide demonstrated comparable efficacy and safety profiles in the overall population, and their efficacy in patients with high-volume disease or low-volume disease was also similar. Conclusion: ARSis sequential therapy did not significantly differ from ARSis combined therapy in improving OS and PFS among patients with mHSPC, and thus can be considered as a viable treatment option. [ABSTRACT FROM AUTHOR]

Background: Nodes are the second site for prostate cancer recurrence. Whole-pelvic radiotherapy (WPRT) has shown superiority over nodal stereotactic body radiotherapy (SBRT) in two retrospective cohorts. We aimed to compare both modalities and assess factors associated with treatment outcomes. Materials and methods: This retrospective multicentric cohort study included patients from five institutions spanning from 2010 to 2022. Patients had a history of prostatic adenocarcinoma classified as N0 M0 at diagnosis with a first nodal-only pelvic castration-sensitive recurrence. Failure-free survival (FFS) was defined as the time from the end of RT to the first failure event–biochemical or imaging recurrence, or death. Results: A total of 147 patients (pts) were analyzed, mainly treated for a recurrence after initial prostatectomy (87%), with 64 (43.5%) undergoing SBRT and 83 (56.5%) undergoing WPRT. SBRT was chosen mainly for dosimetric constraints (67%) and was associated with a lower rate of concomitant androgen deprivation therapy (ADT) prescription. With a median follow-up of 68 months [inter-quartile range (IQR) = 51], FFS was significantly lower in the SBRT group (p < 0.0001). In multivariable analysis, WPRT and ADT were associated with a longer FFS. Factors associated with a longer FFS after SBRT included associated ADT, lower prostate-specific antigen (PSA) levels, a PSA doubling time >6 months, and a Gleason score <8. SBRT was associated with a lower rate of genitourinary and gastrointestinal grade ≥2 complications. Discussion: For an isolated pelvic nodal prostate cancer recurrence, SBRT is associated with a shorter FFS compared to WPRT. SBRT is often more convenient for patients and leaves further pelvic salvage options available, so it can be explored as an option for well-informed patients. [ABSTRACT FROM AUTHOR]

Objectives: To assess the impact of differences in Prostate-Specific Antigen (PSA) testing rates on prostate cancer (PCa) diagnosis and PCa-specific mortality among Māori men in a New Zealand (NZ) population. Patients and Methods: Māori men aged 40 years or older, without a history of PCa, with a PSA test between 2006 and 2018 were included. The cohort was divided into two groups; the “screened group” (ScG) consisting of men who had at least one PSA test every four years or less, and the “non-screened group” (non-SG). We measured the rate of cancer diagnoses and used competing risk analysis to assess survival. Results: The study cohort included 63,939 Māori men, with 37,048 (58%) in the ScG. PCa was more frequently diagnosed in the ScG (3.7% vs. 3.0%, P < 0.001). A higher proportion of high-grade cancers were found in the non-SG (32.7% vs. 25.6%, P = 0.001). The 10-year cancer-specific survival was significantly higher in the ScG (99.4% vs. 98.5%, P < 0.001). In a multivariable risk model, PSA testing frequency was an independent predictor of PCa mortality. (HR 2.43, [95% CI 1.97–3.01], P < 0.001). Conclusions: In a cohort of only Māori men, lower PSA testing rates were associated with a higher risk of PCa-related death. Therefore, regular PSA testing for Māori could improve cancer-specific survival among Māori men. Regular PSA testing should be considered a priority area for improving PCa survival in this population. [ABSTRACT FROM AUTHOR]

The prognostic value of prostate-specific antigen (PSA) kinetics in primary high-volume metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with novel hormonal therapy agents is still unclear. Here, we retrospectively reviewed the data of 102 patients with primary high-volume mHSPC who received novel hormonal therapy agents. The median follow-up was 32.25 ± 14.51 months and the median nadir PSA (nPSA) was 0.20 (0.06, 11.71) ng/mL after treatment. The mean time to nPSA was 10.82 ± 7.27 months and 55 patients (53.9%) had a PSA-density (PSA-D) ≤ 0.08 at 3-months. Univariate and multivariate Cox regression analyses showed that the absence of visceral metastases, nPSA ≤ 0.2 and PSA-D ≤ 0.08 were independent prognostic factors for better PFS and OS (all P < 0.05). Moreover, patients with nPSA ≤ 0.2 and PSA-D ≤ 0.08 had the best PFS and OS, and the combination of the nPSA and PSA-D had a better predictive accuracy for PFS and OS than nPSA and PSA-D alone. Thus, Visceral metastases, nPSA and PSA-D were independent prognostic factors for primary high-volume mHSPC patients treated with novel hormonal therapy agents. Patients with lower nPSA and PSA-D had a best survival outcome, and the combination of nPSA and PSA-D had a better effect on prognosis predicting. [ABSTRACT FROM AUTHOR]

Prostate cancer (PCa) is a clinically heterogeneous disease. Predicting clinically significant PCa with low–intermediate prostate-specific antigen (PSA), which often includes aggressive cancers, is imperative. This study evaluated the predictive accuracy of deep learning analysis using multimodal medical data focused on clinically significant PCa in patients with PSA ≤ 20 ng/mL. Our cohort study included 178 consecutive patients who underwent ultrasound-guided prostate biopsy. Deep learning analyses were applied to predict clinically significant PCa. We generated receiver operating characteristic curves and calculated the corresponding area under the curve (AUC) to assess the prediction. The AUC of the integrated medical data using our multimodal deep learning approach was 0.878 (95% confidence interval [CI]: 0.772–0.984) in all patients without PSA restriction. Despite the reduced predictive ability of PSA when restricted to PSA ≤ 20 ng/mL (n = 122), the AUC was 0.862 (95% CI: 0.723–1.000), complemented by imaging data. In addition, we assessed clinical presentations and images belonging to representative false-negative and false-positive cases. Our multimodal deep learning approach assists physicians in determining treatment strategies by predicting clinically significant PCa in patients with PSA ≤ 20 ng/mL before biopsy, contributing to personalized medical workflows for PCa management. [ABSTRACT FROM AUTHOR]