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Objectives: To explore the factors affecting the lymph node metastasis (LNM) detection performance of prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) and to evaluate its prognostic value for biochemical recurrence after radical prostatectomy (RP). Methods: Patients who had intermediate- or high-risk prostate cancer and underwent robot-assisted (RA)RP between 2017 and 2021 were included. Initial lymph node staging was carried out using PSMA PET/CT. Sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values were calculated. A cut-off value for LNM tumor deposit size that maximizes specificity was investigated and a post hoc specificity analysis was carried out. In survival analysis for biochemical progression-free survival (bPFS) after RP, Kaplan–Meier curves of molecular imaging (mi)N0 and miN1 patients were compared using the log-rank test and separate Cox regression models were developed to reveal the significance of PSMA PET/CT staging in pre- and post-surgery settings. Results: In 583 patients with a prevalence of pathology-proven LNM of 27.4%, overall sensitivity, specificity, PPV, and NPV of PSMA PET/CT per patient were 26.3% [95%CI 18.9–35.5], 93.9% [95%CI 84.9–100], 61.8% [95%CI 44.5–83.5], and 77.1% [95%CI 69.7–85.1], respectively. PSMA PET/CT showed a better sensitivity as LNM tumor deposit size increased (p = 0.003 OR 2.4 [95%CI 1.3–4.4]) and a better specificity in pT3-4 tumors (96.1%) versus pT2 (91.1%, p = 0.024 OR 2.7 [95%CI 1.1–6.3]). After adjustment according to 5.5 mm LNM tumor deposit size, which showed the best discriminative performance (AUC: 0.905 [95%CI 0.804–1.000, p < 0.001]), overall sensitivity tripled (90.2%, p < 0.001). The 1-year bPFS was 56.0% and 83.3% for miN1 and miN0 patients, respectively (p < 0.001). Whereas miN0pN1 was not, miN1pN1 disease was independently associated with decreased bPFS (HR:2.1 95%CI 1.3–3.4, p < 0.001). Conclusions: PSMA PET/CT has a lymph node tumor burden-dependent and cohort-driven diagnostic ability but consequently a strong independent prognostic value for predicting biochemical recurrence after RARP. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether combination treatment of prostate‐specific membrane antigen (PSMA)‐based radioguided surgery (RGS) with short‐term androgen deprivation therapy (ADT) improves oncological outcomes in men with oligorecurrent prostate cancer (PCa) as compared to treatment with short‐term ADT only. Methods: The TRACE‐II study is an investigator‐initiated, prospective, randomised controlled clinical trial. Patients (aged >18 years) with hormone‐sensitive recurrent PCa after radical prostatectomy or radiotherapy (brachytherapy or external beam radiotherapy), with involvement of ≤2 lymph nodes or local oligorecurrent disease within the pelvis as determined by PSMA positron emission tomography (PET)/computed tomography (CT) are randomly assigned in a 1:1 ratio between 6‐month ADT (Arm A) or 6‐month ADT plus RGS (Arm B). The primary objective is to determine clinical progression‐free survival (CPFS) at 24 months. After PSMA‐RGS, CPFS is defined as the time between the start of treatment and the appearance of a re‐recurrence (any N1 or M1) as suggested by PSMA‐PET/CT or symptoms related to progressive PCa, or death from any cause. The secondary objectives include metastasis‐free survival at 2, 5 and 10 years, biochemical progression‐free survival at 2 years, and patient‐reported quality of life at 2, 5 and 10 years. A total of 60 patients, 30 per arm, will be included. The trial is powered (80%) to detect at least a 30% absolute difference in CPFS between the two study arms in the period 2 years after randomisation. We expect to enrol the required participants in 3 years. The study has an expected duration of 5 years in total. Conclusions: Combining RGS with short‐term ADT might be oncologically beneficial for patients with oligorecurrent PCa. In this first randomised controlled trial, we are investigating the potential oncological benefits of this combined treatment, while also focusing on maintaining quality of life. [ABSTRACT FROM AUTHOR]

Purpose: Prostate-specific membrane antigen (PSMA) positron emission tomography/ computed tomography (PET/CT) is recognized as the most accurate imaging modality for detection of metastatic high-risk prostate cancer (PCa). Its role in the local staging of disease is yet unclear. We assessed the intra- and interobserver variability, as well as the diagnostic accuracy of the PSMA PET/CT based molecular imaging local tumour stage (miT-stage) for the local tumour stage assessment in a large, multicentre cohort of patients with intermediate and high-risk primary PCa, with the radical prostatectomy specimen (pT-stage) serving as the reference standard. Methods: A total of 600 patients who underwent staging PSMA PET/CT before robot-assisted radical prostatectomy was studied. In 579 PSMA positive primary prostate tumours a comparison was made between miT-stage as assessed by four nuclear physicians and the pT-stage according to ISUP protocol. Sensitivity, specificity and diagnostic accuracy were determined. In a representative subset of 100 patients, the intra-and interobserver variability were assessed using Kappa-estimates. Results: The sensitivity and specificity of the PSMA PET/CT based miT-stage were 58% and 59% for pT3a-stage, 30% and 97% for ≥ pT3b-stage, and 68% and 61% for overall ≥ pT3-stage, respectively. No statistically significant differences in diagnostic accuracy were found between tracers. We found a substantial intra-observer agreement for PSMA PET/CT assessment of ≥ T3-stage (k 0.70) and ≥ T3b-stage (k 0.75), whereas the interobserver agreement for the assessment of ≥ T3-stage (k 0.47) and ≥ T3b-stage (k 0.41) were moderate. Conclusion: In a large, multicentre study evaluating 600 patients with newly diagnosed intermediate and high-risk PCa, we showed that PSMA PET/CT may have a value in local tumour staging when pathological tumour stage in the radical prostatectomy specimen was used as the reference standard. The intra-observer and interobserver variability of assessment of tumour extent on PSMA PET/CT was moderate to substantial. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the additional value of prostate‐specific membrane antigen positron emission tomography (PSMA‐PET) to conventional diagnostic tools to select patients for hemi‐ablative focal therapy (FT). Patients and Methods: We performed a retrospective analysis on a multicentre cohort (private and institutional) of 138 patients who underwent multiparametric magnetic resonance imaging (mpMRI), PSMA‐PET, and systematic biopsies prior to radical prostatectomy between January 2011 and July 2021. Patients were eligible when they met the consensus criteria for FT: PSA <15 ng/mL, clinical/radiological T stage ≤T2b, and International Society of Urological Pathology (ISUP) grade 2–3. Clinically significant prostate cancer (csPCa) was defined as ISUP grade ≥2, extracapsular extension >0.5 mm or seminal vesicle involvement at final histopathology. The diagnostic accuracy of mpMRI, systematic biopsies and PSMA‐PET for csPCa (separate and combined) was calculated within a four‐quadrant prostate model by receiver‐operating characteristic and 2 × 2 contingency analysis. Additionally, we assessed whether the diagnostic tools correctly identified patients suitable for hemi‐ablative FT. Results: In total 552 prostate quadrants were analysed and 272 (49%) contained csPCa on final histopathology. The area under the curve, sensitivity, specificity, positive predictive value and negative predictive value for csPCa were 0.79, 75%, 83%, 81% and 77%, respectively, for combined mpMRI and systematic biopsies, and improved after addition of PSMA‐PET to 0.84, 87%, 80%, 81% and 86%, respectively (P < 0.001). On final histopathology 46/138 patients (33%) were not suitable for hemi‐ablative FT. Addition of PSMA‐PET correctly identified 26/46 (57%) non‐suitable patients and resulted in 4/138 (3%) false‐positive exclusions. Conclusions: Addition of PSMA‐PET to the conventional work‐up by mpMRI and systematic biopsies could improve selection for hemi‐ablative FT and guide exclusion of patients for whom whole‐gland treatments might be a more suitable treatment option. [ABSTRACT FROM AUTHOR]

Objective: To assess whether a diagnostic pathway in which prostate‐specific membrane antigen (PSMA) positron‐emission tomography (PET)/computed tomography (CT) is used as a single imaging modality is feasible to guide targeted biopsy and to detect clinically significant prostate cancer (csPCa) in biopsy‐naïve men at high‐risk of disease. Patients and Methods: A total of 60 men with a prostate‐specific antigen (PSA) level of 20–50 ng/mL underwent 18F‐PSMA(DCFPyL)‐PET/CT prior to prostate biopsies in this prospective, non‐randomised cohort study. Magnetic resonance imaging (MRI) was not performed. Using a 12‐segment mapping model of the prostate, PSMA‐guided targeted biopsy was performed along with systematic biopsies. The detection rate of PCa and csPCa was assessed for combined systematic and targeted biopsy, and for targeted biopsy only. csPCa was defined as a prostate biopsy with an International Society of Uropathology (ISUP) Grade Group ≥2. Results: Lesions suspicious for PCa in the prostate gland were observed on all PSMA‐PET/CTs. A total of 27/60 men (45%) already had metastatic disease on staging 18F‐PSMA(DCFPyL)‐PET/CT. Combined PSMA‐guided targeted and systematic biopsies detected PCa in 56/60 (93.3%) patients, with 52 of them (92.9%) having csPCa. PSMA‐guided targeted biopsy, if performed as a single biopsy modality, identified PCa in 52/60 men (86.7%) and in 27/27 men (100%) men with metastases. Conclusions: Using the PSMA‐driven single imaging modality pathway in biopsy‐naïve men at high‐risk of PCa, a substantial number of diagnostic MRI scans could be avoided while at the same time obtaining adequate targeting, staging, and detection of csPCa. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the association between the 68Ga- or 18F-radiolabeled prostate-specific membrane antigen (PSMA) tracer expression, represented by the maximum standardised uptake value (SUVmax) of the dominant intraprostatic lesion, and biochemical recurrence (BCR) in primary prostate cancer (PCa) patients prior to robot-assisted radical prostatectomy (RARP). This was a retrospective, multi-centre cohort study of 446 patients who underwent [68Ga]Ga-PSMA-11 (n = 238) or [18F]DCFPyL (n = 206) Positron Emission Tomography/Computed Tomography (PET/CT) imaging prior to RARP. SUVmax was measured in the dominant intraprostatic PCa lesions. [18F]DCFPyL patients were scanned 60 ([18F]DCFPyL-60; n = 106) or 120 ([18F]DCFPyL-120; n = 120) minutes post-injection of a radiotracer and were analysed separately. To normalise the data, SUVmax was log transformed for further analyses. During a median follow-up of 24 months, 141 (30.4%) patients experienced BCR. Log2SUVmax was a significant predictor for BCR (p < 0.001). In the multivariable analysis accounting for these preoperative variables: initial prostate-specific antigen (PSA), radiologic tumour stage (mT), the biopsy International Society of Urological Pathology grade group (bISUP) and the prostate imaging and reporting data system (PI-RADS), Log2SUVmax was found to be an independent predictor for BCR in [68Ga]Ga-PSMA-11 (HR 1.32, p = 0.04) and [18F]DCFPyL-120 PET/CT scans (HR 1.55, p = 0.04), but not in [18F]DCFPyL-60 ones (HR 0.92, p = 0.72). The PSMA expression of the dominant intraprostatic lesion proved to be an independent predictor for BCR in patients with primary PCa who underwent [68Ga]Ga-PSMA-11 or [18F]DCFPyL-120 PET/CT scans, but not in those who underwent [18F]DCFPyL-60 PET/CT scans. [ABSTRACT FROM AUTHOR]

Objective: To investigate the incidences of prostate-specific membrane antigen (PSMA) thyroid incidentaloma (PTI) using different methods to define PTI, to compare the incidence of PTI among different PSMA PET tracers, and to evaluate the clinical consequences of PTI. Methods: PSMA PET/CT scans in consecutive patients with primary prostate cancer were analyzed for the presence of PTI using a structured visual (SV) analysis reporting any elevated thyroidal uptake; a semi-quantitative (SQ) analysis using a SUVmax thyroid/bloodpool (t/b) ratio ≥ 2.0 as cutoff; and an analysis of PTI incidence in the clinical reports (RV analysis). Results: A total of 502 patients were included. The incidence of PTIs was 22% in the SV analysis, 7% in the SQ analysis, and 2% in the RV analysis. PTI incidences differed significantly from 29 to 64% (SQ, resp. SV analysis) for [18F]PSMA-1007, 7 to 23% for [68Ga]PSMA-11, 2 to 8% for [18F]DCFPyL, and to 0% for [18F]PSMA-JK-7. The majority of PTI in the SV and SQ analyses consisted of diffuse (72–83%) and/or only slightly elevated thyroidal uptake (70%). Inter-observer agreement in the SV analysis was substantial (kappa = 0.76–0.78). During follow-up (median 16.8 months), there were no thyroid-related adverse events except in three patients. Conclusions: The incidence of PTI varies greatly among different PSMA PET tracers and is strongly dependent on the analysis method applied. PTI may safely be restricted to focal thyroidal uptake with a SUVmax t/b ratio ≥ 2.0. The clinical pursuit of a PTI must be weighed up to the expected outcome of the underlying disease. Key Points: • Thyroid incidentalomas (PTIs) are recognized in PSMA PET/CT. • Incidence of PTI varies greatly among PET tracers and analysis methods. • Incidence of thyroid-related adverse events in PTI cases is low. [ABSTRACT FROM AUTHOR]

Purpose: A prostate-specific membrane antigen (PSMA) thyroid incidentaloma (PTI) is an unexpected, PSMA-avid thyroid lesion, newly detected during the investigation of an unrelated condition using PSMA PET/CT. The aim of this study is to examine the incidence and clinical significance of PTI and the associated management strategies since the implementation of the PSMA PET/CT scan. Methods: This study involves a retrospective cohort study of 61 PTI cases depicted on PSMA PET/CT scans performed between January 2016 and July 2021, almost exclusively for (re)staging prostate cancer. The medical records of the included cases were retrospectively reviewed and data of the PSMA PET/CT scans, primary malignancy, thyroid diagnostics, treatment, and follow-up were collected. Results: PTI was reported in 1.1% of the patients who underwent oncologic PSMA PET/CT scans included in this study. Two PTI cases had a histologically proven thyroid cancer: one a benign thyroid lesion and one a metastasis of a renal cell carcinoma. In none of the cases in whom any form of further thyroid workup was withheld, the PTI became clinically relevant during follow-up (median 1.8 years (1.1–3.3)). Six patients (10%) died due to their primary cancer. Conclusion: The incidence of thyroid incidentalomas on PSMA PET/CT was low (1.1%) in this large, two-center experience. Less than half of the PTI cases were analyzed and the risk of malignancy, despite being low, was not negligible. The clinical outcome was good using a standard diagnostic workup for PTI, while the prognosis of the patient was determined by the primary malignancy. The consideration to analyze and treat PTI cases should be part of the shared decision-making in cancer patients. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the association between intraprostatic, intratumoral maximum standardised uptake values (SUVmax) on prostate‐specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in patients with prostate cancer (PCa) prior to robot‐assisted radical prostatectomy (RARP) and pathology outcomes, including pathological International Society of Urological Pathology score (pISUP) and lymph node (LN) status (pN0/pN1). Patients and Methods: A bi‐centric, secondary analysis of two previous, prospective cohort studies was performed in 318 patients with biopsy confirmed PCa and who were scheduled for RARP. Before surgery, patients received a PSMA PET/CT with either 68Ga‐PSMA‐11 (59% of the patients) or 18F‐PSMA (DCFPyL; 41%) as radiotracer. PET/CT images were analysed both visually and semi‐quantitatively by measuring the SUVmax of the most intense suspect lesion in the prostate. The association between the SUVmax of the primary tumour and pre‐ and postoperative variables was analysed. Results: The SUVmax was associated with clinical and biopsy preoperative variables, as well as with pISUP score and pathological tumour stage. Patients with a pISUP of ≤2 showed significantly lower SUVmax compared to patients with a pISUP of >2 for both tracers (SUVmax18F‐PSMA: median 5.1 vs 9.6, P = 0.002; SUVmax68Ga‐PSMA‐11: 6.6 vs 8.6, P = 0.003). Moreover, patients with pN1 had significantly higher median SUVmax than those with pN0/pNx for both tracers (SUVmax18F‐PSMA: 7.9 vs 12.3, P = 0.04; SUVmax68Ga‐PSMA‐11: 7.6 vs 12.0, P < 0.001). On multivariable logistic regression analysis, the intraprostatic SUVmax was an independent predictor of pN1 for both 68Ga‐PSMA‐11 (per doubling: odds ratio [OR] 1.96, 95% confidence interval [CI] 1.27–3.01)) and 18F‐PSMA (per doubling: OR 1.79, 95% CI 1.06–3.03). Conclusion: Intraprostatic, intratumoral PSMA intensity on PET/CT, as semi‐quantitatively expressed by SUVmax, may be a valuable innovative biomarker in patients with localised PCa, as it is highly associated with known conventional prognostic factors, such as pISUP and LN status. [ABSTRACT FROM AUTHOR]

Objectives: To identify predictors of early oncological outcomes in patients who opt for robot‐assisted laparoscopic radical prostatectomy (RARP) for localized prostate cancer (PCa), including conventional prognostic variables as well as multiparametric magnetic resonance imaging (mpMRI) and prostate‐specific membrane antigen (PSMA) positron emission tomography (PET). Patients and Methods: This observational study included 493 patients who underwent RARP and extended pelvic lymph node dissection (ePLND) for unfavourable intermediate‐ or high‐risk PCa. Outcome measurement was biochemical progression of disease, defined as any postoperative prostate‐specific antigen (PSA) value ≥0.2 ng/mL, or the start of additional treatment. Cox regression analysis was performed to assess predictors for biochemical progression, including initial PSA value, biopsy Grade Group (GG), T‐stage on mpMRI, and lymph node status on PSMA PET imaging (miN0 vs miN1). Results: The median (interquartile range) total follow‐up of all included patients without biochemical progression was 12.6 (7.5–22.7) months. When assessing biochemical progression after surgery, initial PSA value (per doubling; odds ratio [OR] 1.22, 95% confidence interval [CI] 1.07–1.40; P = 0.004), biopsy GG ≥4 vs GG 1–2 (OR 1.83, 95% CI 1.18–2.85; P = 0.007), T‐stage on mpMRI (rT3a vs rT2: OR 2.13, 95% CI 1.39–3.27; P = 0.001; ≥rT3b vs rT2: OR 4.78, 95% CI 3.20–7.16; P < 0.001) and miN1 on PSMA PET imaging (OR 2.94, 95% CI 2.02–4.27; P < 0.001) were independent predictors of early biochemical progression of disease. Conclusion: Initial PSA value, biopsy GG ≥4, ≥rT3 disease on mpMRI and miN1 disease on PSMA PET were predictors of early biochemical progression after RARP. Identifying these patients with an increased risk of early biochemical progression after surgery may have major implications for patient counselling in radical treatment decisions and on patient selection for modern (neo‐)adjuvant and systematic treatments. [ABSTRACT FROM AUTHOR]

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Purpose: Prostate-specific membrane antigen (PSMA) agents, such as [68Ga]Ga-PSMA-11, have an unprecedented accuracy in staging prostate cancer (PCa) and detecting disease recurrence. PSMA PET/CT may also be used for response monitoring by displaying molecular changes, instead of morphological changes alone. However, there are still limited data available on the variability in biodistribution and intra-prostatic uptake of PSMA targeting radiotracers. Therefore, the aim of this study was to assess the repeatability of [68Ga]Ga-PSMA-11 uptake in primary PCa patients in a 4-week interval. Methods: Twenty-four primary PCa patients were prospectively included, who already were scheduled for [68Ga]Ga-PSMA-11 PET/CT scan on clinical indication (≥ cT3, Gleason score ≥ 7 or PSA ≥ 20 ng/mL). These patients received two [68Ga]Ga-PSMA-11 PET/CT scans with a 4-week interval. No treatment was started in between the scans. Semiquantitative measurements (SULmax, SULmean, and SULpeak) were determined in the prostate tumor, normal tissues, and blood pool. The repeatability coefficient of every region was determined. All scans were visually analyzed by two nuclear medicine physicians. Results: Within-subject coefficient of variation of [68Ga]Ga-PSMA-11 uptake between the two scans was on average 10% in the prostate tumor, normal tissues (liver, kidney, parotid), and blood pool. The repeatability coefficient of the prostate tumor was 18% for SULpeak and 22% for SULmax. Lesion uptake was visually different in 5 patients, though not clinically relevant. Conclusion: Results of test-retest [68Ga]Ga-PSMA-11 PET/CT scans in a 4-week interval show that [68Ga]Ga-PSMA-11 uptake is repeatable, with a clinical irrelevant variation in tumor and physiological distribution. Based on the presented repeatable uptake, [68Ga]Ga-PSMA-11 PET/CT scans can potentially be used for disease surveillance and therapy response monitoring. Changes in uptake larger than the RC are therefore likely to reflect actual biological changes in PSMA expression. Trial registration NL8263 at Trialregister.nl retrospectively registered on 03-01-2020. https://www.trialregister.nl/trial/8263 [ABSTRACT FROM AUTHOR]

Background: To evaluate the impact of Gallium-68 [68Ga] labeled prostate specific membrane antigen (PSMA) positron emission tomography (PET)/X-ray computed tomography (CT) compared with conventional imaging on staging and clinical management of men evaluated for primary prostate cancer (PCa).Methods: Men with newly diagnosed biopsy-proven PCa who had been staged with a conventional staging protocol including bone scintigraphy (BS) and additionally underwent [68Ga]PSMA PET/CT, were evaluated retrospectively. Imaging findings from BS, magnetic resonance imaging (MRI) and/or CT were categorized regarding locoregional nodal (N) and distant metastasis (M) status as negative, positive or equivocal before and after addition of the information of PET/CT. Also, the imaging-based level of confidence (LoC) in correct assessment of N and M status was scored. Impact of PET/CT on clinical management was evaluated by the percentage of treatment category changes after PET/CT as determined in the multidisciplinary tumour board.Results: Sixty-four men with intermediate and high-risk PCa were evaluated. With additional information of PET/CT, N status was upstaged in 23%, and downstaged in 9%. M status was upstaged in 13%, and downstaged in 23%. A net increase in LoC of 20% was noted, mainly regarding M status. Treatment category changed from palliative to curative in 9%, and from curative to palliative in 3%. An undecided treatment plan changed to curative in 14%, as well as to palliative in another 9%. In total, a 36% treatment category change was noted. High negative predictive value of PET/CT for M status was indicated by 27 patients that underwent robot-assisted radical prostatectomy and reached postoperative biochemical disease-free status or had a likely other site of disease recurrence.Conclusions: PSMA PET/CT can cause considerable changes in N and M staging, as well as in management compared to conventional staging. Findings of this study support the replacement of BS and CT by PSMA PET/CT in staging primary PCa. [ABSTRACT FROM AUTHOR]

Objectives: To review the literature to determine the sensitivity and specificity of gallium‐68 prostate‐specific membrane antigen (68Ga‐PSMA) positron‐emission tomography (PET) for detecting pelvic lymph node metastases in patients with primary prostate cancer (PCa), and the positive predictive value in patients with biochemical recurrence (BCR) after initial curative treatment, and, in addition, to determine the detection rate and management impact of 68Ga‐PSMA PET in patients with BCR after radical prostatectomy (RP). Materials and Methods: We performed a comprehensive literature search. Search terms used in MEDLINE, EMBASE and Science Direct were '(PSMA, 68Ga‐PSMA, 68Gallium‐PSMA, Ga‐68‐PSMA or prostate‐specific membrane antigen)' and '(histology, lymph node, staging, sensitivity, specificity, positive predictive value, recurrence, recurrent or detection)'. Relevant abstracts were reviewed and full‐text articles obtained where possible. References to and from obtained articles were searched to identify further relevant articles. Results: Nine retrospective and two prospective studies described the sensitivity and specificity of 68Ga‐PSMA PET for detecting pelvic lymph node metastases before initial treatment, which ranged from 33.3% to 100% and 80% to 100%, respectively. In eight retrospective studies, the positive predictive value of 68Ga‐PSMA PET in patients with BCR before salvage lymph node dissection ranged from 70% to 100%. The detection rate of 68Ga‐PSMA PET in patients with BCR after RP in the PSA subgroups <0.2 ng/mL, 0.2–0.49 ng/mL and 0.5 to <1.0 ng/mL ranged from 11.3% to 50.0%, 20.0% to 72.7% and 25.0% to 87.5%, respectively. Conclusion: The review results showed that 68Ga‐PSMA PET had a high specificity for the detection of pelvic lymph node metastases in primary PCa. Furthermore, 68Ga‐PSMA PET had a very high positive predictive value in detecting lymph node metastases in patients with BCR. By contrast, sensitivity was only moderate; therefore, based on the currently available literature, 68Ga‐PSMA PET cannot yet replace pelvic lymph node dissection to exclude lymph node metastases. In the salvage phase, 68Ga‐PSMA PET had both a high detection rate and impact on radiotherapy planning in early BCR after RP. [ABSTRACT FROM AUTHOR]

The DROP-IN gamma probe facilitates minimally invasive, robot-assisted prostate-specific membrane antigen–targeted radioguided surgery in patients with recurrent prostate cancer. This procedure holds promise for improving the intraoperative identification and removal of prostate cancer lesions. It has been proven that intraoperative prostate-specific membrane antigen (PSMA)-targeted radioguidance is valuable for the detection of prostate cancer (PCa) lesions during open surgery. Rapid extension of robot-assisted, minimally invasive surgery has increased the need to make PSMA-radioguided surgery (RGS) robot-compliant. To evaluate whether the miniaturized DROP-IN gamma probe facilitates translation of PSMA-RGS to robotic surgery in men with recurrent PCa. This prospective feasibility study included 20 patients with up to three pelvic PCa recurrences (nodal or local) on staging PSMA positron emission tomography (PET) after previous curative-intent therapy. Robot-assisted PSMA-RGS using the DROP-IN gamma probe was carried out 19–23 h after intravenous injection of 99mtechnetium PSMA-Investigation & Surgery (99mTc-PSMA-I&S). The primary endpoint was the feasibility of robot-assisted PSMA-RGS. Secondary endpoints were a comparison of the radioactive status (positive or negative) of resected specimens and final histopathology results, prostate-specific antigen (PSA) response following PSMA-RGS, and complications according to the Clavien-Dindo classification. Using the DROP-IN probe, 19/21 (90%) PSMA-avid lesions could be resected robotically. On a per-lesion basis, the sensitivity and specificity of robot-assisted PSMA-RGS was 86% and 100%, respectively. A prostate-specific antigen (PSA) reduction of >50% and a complete biochemical response (PSA <0.2 ng/ml) were seen in 12/18 (67%) and 4/18 (22%) patients, respectively. During follow-up of up to 15 mo, 4/18 patients (22%) remained free of biochemical recurrence (PSA ≤0.2 ng/ml). One patient suffered from a Clavien-Dindo grade >III complication. The DROP-IN probe helps in realizing robot-assisted PSMA-RGS. The procedure is technically feasible for intraoperative detection of nodal or local PSMA-avid PCa recurrences. A device called the DROP-IN probe facilitates minimally invasive, robot-assisted surgery guided by radioactive tracers in patients with recurrent prostate cancer. This procedure holds promise for improving the intraoperative identification and removal of prostate cancer lesions. [ABSTRACT FROM AUTHOR]

Different nomograms exist for the preoperative prediction of pelvic lymph-node metastatic disease in individual patients with prostate cancer (PCa). These nomograms do not incorporate modern imaging techniques such as prostate-specific membrane antigen (PSMA) positron emission tomography (PET). To determine the predictive performance of the Briganti 2017, Memorial Sloan Kettering Cancer Center (MSKCC), and Briganti 2019 nomograms with the addition of PSMA-PET in an international, multicenter, present-day cohort of patients undergoing robot-assisted radical prostatectomy (RARP) and extended pelvic lymph-node dissection (ePLND) for localized PCa. All 757 eligible patients who underwent a PSMA-PET prior to RARP and ePLND in three reference centers for PCa surgery between January 2016 and November 2020 were included. Performance of the three nomograms was assessed using the receiver operating characteristic curve–derived area under the curve (AUC), calibration plots, and decision curve analyses. Subsequently, recalibration and addition of PSMA-PET to the nomograms were performed. Overall, 186/757 patients (25%) had pelvic lymph-node metastatic (pN1) disease on histopathological examination. AUCs of the Briganti 2017, MSKCC, and Briganti 2019 nomograms were 0.70 (95% confidence interval [95% CI]: 0.64–0.77), 0.71 (95% CI: 0.65–0.77), and 0.76 (95% CI: 0.71–0.82), respectively. PSMA-PET findings showed a significant association with pN1 disease when added to the nomograms (p < 0.001). Addition of PSMA-PET substantially improved the discriminative ability of the models yielding cross-validated AUCs of 0.76 (95% CI: 0.70–0.82), 0.77 (95% CI: 0.72–0.83), and 0.82 (95% CI: 0.76–0.87), respectively. In decision curve analyses, the addition of PSMA-PET to the three nomograms resulted in increased net benefits. The addition of PSMA-PET to the previously developed nomograms showed substantially improved predictive performance, which suggests that PSMA-PET is a likely future candidate for a modern predictive nomogram. Different tools have been developed to individualize the prediction of prostate cancer spread to lymph nodes before surgery. We found that the inclusion of modern imaging (prostate-specific membrane antigen positron emission tomography) improved substantially the overall performance of these prediction tools. The addition of prostate-specific membrane antigen positron emission tomography (PSMA-PET) to the previously developed nomograms for the prediction of pelvic lymph-node metastases showed substantially improved predictive performance, which suggests that PSMA-PET is a likely future candidate for a modern predictive nomogram. [ABSTRACT FROM AUTHOR]