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Introduction: To evaluate the detection rate for prostate cancer (PCa) performing multiparametric magnetic resonance imaging (mpMRI) fusion targeted biopsy (TPBx) combined only with ipsilateral systematic prostate biopsy (SPBx). Materials and Methods: From January 2023 to December 2023, 495 men with clinical suspicion of PCa underwent transperineal SPBx plus TPBx in the presence of PI-RADS score lesions ≥ 3. Results: In 250/495 men (50.5%) a PCa was found, while 36/250 (14.4%) men had negative mpMRI. In comparison to TPBx, SPBx diagnosed a higher number of indolent PCa, 38.5 vs. 5.8%, respectively; conversely, SPBx demonstrated a higher detection rate for clinically significant PCa (97.3 vs. 85.4%) in the presence of ISUP Grade Group 2 (GG2). In details, rates were higher in the presence of GG2 (100 vs. 76%), GG3 (85.7 vs. 75.8%) and GG4 (100 vs. 86.4%) tumors. However, in GG5, both SPBx and TPBx diagnosed 100% of csPCa. Furthermore, 89.4% of the cases showed csPCa on the negative mpMRI side. Conclusions: SPBx combined with TPBx maximized csPCa diagnosis; the use of reduced biopsy scheme limited to ipsilateral side of mpMRI lesion plus TPBx missed 11.6% csPCa. Only in the presence of PI-RADS score 5 SPBx and TPBx diagnosed both 100% of csPCa.

Introduction: To evaluate the accuracy of PSMA PET/CT in men with mpMRI PI-RADS score 5 negative biopsy histology. Materials and methods: From January 2011 to January 2023, 180 men with PI-RADS score 5 underwent systematic plus mpMRI/TRUS biopsy; 25/180 (13.9%) patients had absence of cancer and six months from biopsy were submitted to: digital rectal examination, PSA and PSA density exams, mpMRI and 68GaPSMA PET/CT evaluation (standardized uptake value “SUVmax” was reported). Results: In 24/25 (96%) patients PSA and PSA density significantly decreased, moreover, the PI-RADS score was downgraded resulting < 3; in addition, median SUVmax was 7.5. Only 1/25 (4%) man had an increased PSA value (from 10.5 to 31 ng/ml) with a confirmed PI-RADS score 5, SUVmax of 32 and repeated prostate biopsy demonstrating a Gleason score 9/ISUP Grade Group 5 PCa. Conclusions: The strict follow up of men with PI-RADS score 5 and negative histology reduce the risk of missing csPCa especially if PSMA PET/CT evaluation is in agreement with downgrading of mpMRI (PI-RADS score < 3).

Introduction: To evaluate the accuracy of PSMA PET/CT in the diagnosis and clinical staging of prostatic ductal adenocarcinoma (DAC). Materials and methods: Two Caucasian men 58 and 62 years old were admitted to our Department for dysuria: the patients had not familiarity for prostate cancer (PCa), PSA values were 5.6 and 2.8 ng/ml, digital rectal examination was positive, multiparametric magnetic resonance image (mpMRI) showed for both the presence of an index lesion PIRADS score 5. The patients underwent extended transperineal prostate biopsy combined with four mpMRI/TRUS fusion biopsy under sedation and antibiotic prophylaxis; biopsy histology demonstrated the presence of a mixed PCa characterized by DAC and acinar PCa (Grade Group 4/Gleason score 8). The patients underwent clinical staging performing lung and abdominal CT, bone scan and fluoride 18 (18F) PSMA PET/CT. Results: Conventional imaging was negative for distant metastases; 18F-PSMA PET/CT showed in both patients an intraprostatic lesion characterized by a standardized uptake value (SUVmax) equal to 4.6 and 4.9 in the absence of distant lesions suspicious for metastases. Following multidisciplinary evaluation, the patients underwent radical prostatectomy plus extended pelvic lymphadenectomy. Definitive specimen showed the presence in both cases of a mixed pT3bN1 PCa (ductal plus acinar pattern Grade Group 4) with positive surgical margins, neuronal invasion, and nodes metastases (5/20 and 6/24, respectively). Post-operative PSA in the two patients was 0.8 and 0.3 ng/ml, therefore patients underwent adjuvant therapy. Conclusions: Conventional imaging and PSMA PET/CT could result inadequate in clinical staging of DAC, the use of more imaging data (i.e. mpMRI and/or F-18 FDG) could improve overall accuracy.

Introduction: To evaluate the accuracy of 68Ga-prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in the diagnosis of clinically significant prostate cancer (csPCa: Grade Group ≥ 2) in men enrolled in Active Surveillance (AS) protocol. Materials and methods: From May 2013 to December 2021 200 men aged between 52 and 74 years (median age 63) with very low risk PCa were enrolled in an AS protocol study. During the follow up 48/200 (24%) men were upgraded and 10/200 (5%) decided to leave the AS protocol. After five years from confirmatory biopsy (range: 48-60 months) 40/142 (28.2%) consecutive patients were submitted to mpMRI and 68Ga-PSMA PET/CT imaging examinations before scheduled repeated biopsy. All the mpMRI (PI-RADS ≥ 3) and 68Ga-PET/TC standardized uptake value (SUVmax) ≥ 5 index lesions underwent targeted cores (mpMRI-TPBx and PSMA-TPBx) combined with transperineal saturation prostate biopsy (SPBx: median 20 cores). Results: Multiparametric MRI and 68Ga-PSMA PET/CT showed 18/40 (45%) and 9/40 (22.5%) lesions suspicious for PCa. In 3/40 (7.5%) men a csPCa (GG2) was found; 68Ga-PSMA-TPBx vs. mpMRI-TPBx vs. SPBx diagnosed 2/3 (66.6%) vs. 2/3 (66.6%) vs. 3/3 (100%) csPCa, respectively. In detail, mpMRI and 68Ga-PSMA PET/TC demonstrated 16/40 (40%) vs. 7/40 (17.5%) false positive and 1 (33.3%) vs. 1 (33.3%) false negative results. Conclusion: Although 68PSMA PET/CT did not improve the detection for csPCa of SPBx (1 false negative result equal to 33.3% of the cases), at the same time, would have spared 31/40 (77.5%) scheduled biopsies showing a better diagnostic accuracy in comparison with mpMRI (83.3% vs. 70.2%).

Introduction: The reclassification rate for clinically significant prostate cancer (csPCa) in men enrolled in Active Surveillance (AS) as been prospective-ly evaluated. Patients and methods: One hundred patients with very low risk PCa underwent after 8 years a scheduled transperineal prostate biopsy (SPBx = 20 cores) combined with additional mpMRI/TRUS fusion biopsies (4 cores) of lesions PI-RADS scores ≥ 3. All the patients, after initial diagnosis, previously had mpMRI evaluation combined with transperineal saturation prostate biopsy (confirmatory and 3-year scheduled biopsy). Risk reclassification at repeat biopsy triggering the recommen-dation for active treatment was defined as over 3 or more than 10% of positive cores, Gleason score > 6/ISUP Grade Group ≥ 2, greatest percentage of cancer (GPC) > 50%. Results: Multiparametric MRI was suspicious (PI-RADS ≥ 3) in 30 of 100 cases (30.0%); 70 (70.0%) vs. 20 (20.0%) vs. 10 (10.0%) patients had a PI-RADS score ≤ 2 vs. 3 vs. 4, respec-tively. Two (2.0%) patients with PI-RADS score 3 and 4 were upgraded (ISUP Grade Group 2); SPBx and MRI/TRUS fusion biopsy diagnosed 100% and 0% of csPCa, respectively. Conclusions: Transperineal SPBx combined with mpMRI at ini-tial confirmatory biopsy allow to select an high number of men at very low risk of reclassification during the AS follow up (2.0%of the cases at 8 years from diagnosis); these data could be use-ful to reduce the number of scheduled repeated prostate biopsy during the AS follow up.

Introduction: To evaluate the diagnostic accuracy of 68Ga-prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomog-raphy (PET/CT) vs. multiparametric magnetic resonance imag-ing (mpMRI) targeted biopsy (TPBx) in the diagnosis of clinical-ly significant prostate cancer (csPCa: Grade Group ≥ 2). Materials and methods: From January 2021 to June 2022, 100 patients (median age: 66 years) with negative digital rectal examination underwent transperineal prostate biopsy for abnor-mal PSA values (median 7.5 ng/ml). Before prostate biopsy, all patients underwent mpMRI and 68Ga-PET/CT examinations and mpMRI (PI-RADS version 2 ≥ 3) or 68Ga-PET/CT index lesions suspicious for cancer (SUVmax > 5 g/ml) underwent cognitive targeted cores (mpMRI-TPBx and PSMA-TPBx: four cores) com-bined with extended systematic prostate biopsy (eSPBx: median 18 cores). The procedure was performed transperineally using a tru-cut 18-gauge needle under sedation and antibiotic prophy-laxis. Results: PCa was found in 58/100 (58.0%) men; in detail, 44/58 (75.9%) were csPCa; mpMRI and 68Ga-PSMA showed 66/100 (66%) and 62/100 (60%) lesions suspicious for PCa, respective-ly. 68Ga-PSMA-TPBx vs. mpMRI-TPBx vs. eSPBx diagnosed 42 (95.4%) vs. 36 (81.8%) vs. 30 (68.2%) csPCa, respectively; mpMRI-TPBx vs. 68Ga-PSMA-TPBx showed a diagnostic accuracy of 76.9% vs. 84.9% in diagnosing csPCa. Conclusions: 68GaPSMA PET/CT TPBx demonstrated good accuracy in the diagnosis of csPCa, which was not inferior to mpMRI TPBx (84.9% vs. 76.9%) improving the detection rate for cancer of systematic biopsy.

Introduction: The incidence of erectile dysfunction (ED) in men with organ-confined prostate cancer (PCa) submitted to hypofractionated radiotherapy (HRT) has been prospectively evaluated. Materials and methods: From April 2018 to September 2020, 56 patients (median age 70 years) with cT1c PCa were treated by HRT directed to the prostate and seminal vesicle. Median PSA was 8.3 ng/ml; 20 patients (35.7%) vs. 28 (50%) vs. 8 (22.3%) had a PCa Grade Group 1 vs. 2 vs. 3, respectively. All patients underwent hydrogel injection of Space OAR and intraprostatic fiducials before HRT. The prescription dose was 60 Gy in 20 fractions 5 days/week over 4 weeks. During the follow up, PSA, genitourinary (GU) and gastrointestinal (GI) toxicities were evaluated. The sexual function was evaluated by International Index of Erectile Function - 5 (IIEF-5) before, 6 and 18 months from HRT; 32/56 (57.1%) men referred a normal sexual activity before HRT (median IIEF-5 score: 22). Results: Median PSA level at median follow up of 18 months was 0.92 ng/ml and none used adjuvant therapy. One man (1.8%) referred a tardive grade 1 GU complication. At a median follow up of 6 and 18 months, 20/32 (62.5%) kept pretreatment sexual potency (median IIEF-5 score: 21). The 12/32 men who worsened the sexual function following HRT had a median age higher than patients without ED (78 vs. 67 years). Conclusions: The use of hydrogel injection and intraprostatic fiducials followed by HRT allowed to kept pretreatment sexual potency in 62.5% of the cases.

Introduction: To evaluate clinical complications following transperineal prostate biopsy in 8.500 patients. Materials and methods: From January 2000 to January 2022, 8,500 men (median age: 62.8 years) underwent transperineal prostate biopsy; since 2011, 1,850 patients were submitted to mpMRI and in the presence of a PI-RADS score ≥ 3, a transperineal targeted biopsy was added to systematic prostate biopsy (4 cores). All patients underwent antibiotic prophylaxis (2000-2011: levoxacin 500 tablet; 2012-2022: 2 grams intravenous of cefazolin). Among 8.500 men 1.350 (15.8%) vs. 4.520 (53.3%) vs. 2.630 (30.9%) underwent 12 vs. 18 vs. > 24 needle cores, respectively. The prostate biopsy-related complications were evaluated within 20 days from prostate biopsy; the number of patients who needed hospital admission or emergency department visit (EDV) was recorded. Results: Prostate cancer was found in 3.150/8.500 (37.1%) patients; overall, hospital admission and EDV were equal to 1.5% and 8.9% and the side effects were directly correlated with the number of needle cores resulting equal to 17.4% (12 cores), 38.7% (18 cores) and 55.3% (> 24 cores) (p = 0.001). Hospital admission and EDV in men who underwent 12 vs. 18 vs. > 24 cores occurred in 1.5% and 7.4% vs. 1.4% and 8.7% vs. 1.7% and 10.6% (p > 0.05), respectively. Conclusions: Clinical complications following transperineal prostate biopsy involved 35.9% of the patients but only 1.5% of them required hospital admission; urinary tract infection with fever was the most frequent cause of hospital recovery (33.4% of the cases), but none of the patients developed sepsis.