Association of Patient and Imaging-Related Factors With False Negative MRI-Targeted Prostate Biopsies of Suspicious PI-RADS 4 and 5 Lesions.

OBJECTIVE: To investigate specific imaging and patient-related factors associated with a false negative (FN) MRI-targeted prostate fusion biopsies (TBx) of suspicious MRI lesions. METHODS: Retrospective study of men with PI-RADS 4 or 5 lesions November, 2015-December 2020 with TBx and systematic biopsy (SBx) performed. Only FN and true positive (TP) targeted lesions were included. FN biopsy was defined as a negative TBx with a positive systematic core in the ROI or perilesional sextant. Logistic regression was used to determine the association of patient and imaging-specific factors with the probability of a FN TBx. RESULTS: 361 PI-RADS 4 or 5 lesions in 304 patients, including 67 FN (19%) and 294 TP (81%) were included. There was a significant inverse association between lesion size (OR: 0.94, P-value: .02), presence of a suspicious DRE (OR: 0.36, P-value: .02) and PSA density (OR: 0.01, P-value: .004) on the probability of obtaining a FN TBx. There was no association between age, biopsy indication, use of an enema before MRI, prostate size, or discrepant US and MRI segmentation volumes on the probability of a FN TBx. CONCLUSION: In this cohort, SBx detected 19% of csPCa missed on TBx. Smaller PI-RADS 4/5 lesions, lower PSAD values, and a normal DRE were all associated with an increased probability of a FN TBx.

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.

PURPOSE: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. MATERIALS AND METHODS: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. RESULTS: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. CONCLUSIONS: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

Oncologic Outcomes of Definitive Treatments for Low- and Intermediate-Risk Prostate Cancer After a Period of Active Surveillance.

BACKGROUND: To compare oncologic outcomes of different definitive treatment (DT) modalities in a cohort of patients with prostate cancer (PCa) after active surveillance (AS). METHODS: We identified 237 patients with National Comprehensive Cancer Network (NCCN) low- and intermediate-risk prostate cancer diagnosed from 1990 to 2012 who did not undergo immediate DT within 12 months of diagnosis (ie, AS patients as well as watchful waiting and those refusing DT). Charts were examined for clinical/pathologic data and type of DT: surgery (RP), radiation including brachytherapy (XRT), cryotherapy, and androgen deprivation therapy monotherapy (ADT). The impact of DT on oncologic outcomes of biochemical recurrence (BCR), metastasis, disease-specific (DSS), and overall survival (OS) was examined with the Cox proportional hazards model, along with the Kaplan-Meier method and log-rank test. RESULTS: After median time on AS of 63.4 months, 40% of patients underwent DT: 47% XRT, 28% RP, 14% ADT, and 11% cryotherapy. On multivariable analysis, the use of XRT predicted higher BCR (hazard ratio [HR] 6.1, P = .001) and worse overall mortality (HR 2.1, P = .03) compared with other treatments, controlling for age, Charlson Comorbidity Index (CCI), stage, Gleason score, and NCCN risk category. Median follow-up was 71.7 months. On Kaplan-Meier analysis, 10-year OS was superior for RP versus XRT among patients with prostatic specific antigen (PSA) velocity >2.0 ng/mL/y. CONCLUSIONS: Low- and intermediate-risk patients with PCa who progress to DT after AS may be inadequately treated with radiation therapy compared with other DT modalities, especially when pretreatment PSA velocity is > 2 ng/mL/y.

Open radical retropubic prostatectomy gives favourable surgical and functional outcomes after transurethral resection of the prostate.

OBJECTIVES: To assess the peri- and postoperative outcome of patients treated with open radical retropubic prostatectomy (RRP) for prostate cancer and who had previously undergone transurethral resection of the prostate (TURP). PATIENTS AND METHODS: Prospectively collected data from a consecutive series of 1760 patients who had RRP between July 2003 and June 2007 at our institution were used to retrospectively match 62 cases (with previous TURP) with the same number of controls (without previous TURP). Matching variables were patient age, body mass index, prostate volume, preoperative total prostate-specific antigen (PSA) level, Gleason score, pathological stage, and intraoperative nerve-sparing procedure. Complete 1-year follow-up data were available for all patients. All collected data on surgery and perioperative complications were analysed. Functional outcome data at the 1-year follow-up were evaluated by applying an institutional questionnaire. Sexual function was assessed using the abbreviated International Index of Erectile Function-5 questionnaire, and urinary control was evaluated by defining complete urinary control as no pad usage. RESULTS: The rate of complete urinary control rate in cases and controls was similar (81% vs 82%). When nerves were spared, 60% (15/25) of patients in either group were capable of sexual intercourse. The overall positive surgical margin rate was insignificantly higher in cases (19% vs 13, P>0.05). After 1 year of follow-up the biochemical recurrence rate (PSA>0.04 ng/mL) did not differ significantly in patients who had RRP after TURP vs RRP alone (six of 62, 10%, vs five of 62, 8%; P=0.77). CONCLUSIONS: RRP for prostate cancer in patients who have had previous TURP does not result in a higher perioperative complication rate, or a worse functional outcome.