ProsTAV, a clinically useful test in prostate cancer: an extension study.

PURPOSE: To assess the clinical performance of ProsTAV®, a blood-based test based on telomere associate variables (TAV) measurement, to support biopsy decision-making when diagnosing suspicious prostate cancer (PCa). METHODS: Preliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3-10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center's routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined. RESULTS: The mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85-0.95) and specificity of 0.27 (95% CI, 0.19-0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46-0.60) and 0.74 (95% CI, 0.62-0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI. CONCLUSIONS: ProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.

Transperineal laser ablation of the prostate as a treatment for benign prostatic hyperplasia and prostate cancer: The results of a Delphi consensus project.

Objective: To evaluate transperineal laser ablation (TPLA) with Echolaser® (Echolaser® TPLA, Elesta S.p.A., Calenzano, Italy) as a treatment for benign prostatic hyperplasia (BPH) and prostate cancer (PCa) using the Delphi consensus method. Methods: Italian and international experts on BPH and PCa participated in a collaborative consensus project. During two rounds, they expressed their opinions on Echolaser® TPLA for the treatment of BPH and PCa answering online questionnaires on indications, methodology, and potential complications of this technology. Level of agreement or disagreement to reach consensus was set at 75%. If the consensus was not achieved, questions were modified after each round. A final round was performed during an online meeting, in which results were discussed and finalized. Results: Thirty-two out of forty invited experts participated and consensus was reached on all topics. Agreement was achieved on recommending Echolaser® TPLA as a treatment of BPH in patients with ample range of prostate volume, from <40 mL (80%) to >80 mL (80%), comorbidities (100%), antiplatelet or anticoagulant treatment (96%), indwelling catheter (77%), and strong will of preserving ejaculatory function (100%). Majority of respondents agreed that Echolaser® TPLA is a potential option for the treatment of localized PCa (78%) and recommended it for low-risk PCa (90%). During the final round, experts concluded that it can be used for intermediate-risk PCa and it should be proposed as an effective alternative to radical prostatectomy for patients with strong will of avoiding urinary incontinence and sexual dysfunction. Almost all participants agreed that the transperineal approach of this organ-sparing technique is safer than transrectal and transurethral approaches typical of other techniques (97% of agreement among experts). Pre-procedural assessment, technical aspects, post-procedural catheterization, pharmacological therapy, and expected outcomes were discussed, leading to statements and recommendations. Conclusion: Echolaser® TPLA is a safe and effective procedure that treats BPH and localized PCa with satisfactory functional and sexual outcomes.

ProsTAV, a novel blood-based test for biopsy decision management in significant prostate cancer.

BACKGROUND: Current pathways in early diagnosis of prostate cancer (PCa) can lead to unnecessary biopsy procedures. Here, we used telomere analysis to develop and evaluate ProsTAV®, a risk model for significant PCa (Gleason score >6), with the objective of improving the PCa diagnosis pathway. METHODS: This retrospective, multicentric study analyzed telomeres from patients with serum PSA 3-10 ng/mL. High-throughput quantitative fluorescence in-situ hybridization was used to evaluate telomere-associated variables (TAVs) in peripheral blood mononucleated cells. ProsTAV® was developed by multivariate logistics regression based on three clinical variables and six TAVs. The predictive capacity and accuracy of ProsTAV® were summarized by receiver operating characteristic (ROC) curves and its clinical benefit with decision curves analysis. RESULTS: Telomeres from 1043 patients were analyzed. The median age of the patients was 63 years, with a median PSA of 5.2 ng/mL and a percentage of significant PCa of 23.9%. A total of 874 patients were selected for model training and 169 patients for model validation. The area under the ROC curve of ProsTAV® was 0.71 (95% confidence interval [CI], 0.62-0.79), with a sensitivity of 0.90 (95% CI, 0.88-1.0) and specificity of 0.33 (95% CI, 0.24-0.40). The positive predictive value was 0.29 (95% CI, 0.21-0.37) and the negative predictive value was 0.91 (95% CI, 0.83-0.99). ProsTAV® would make it possible to avoid 33% of biopsies. CONCLUSIONS: ProsTAV®, a predictive model based on telomere analysis through TAV, could be used to increase the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/mL.

Evaluation of Quality of Life After Inflatable Penile Implantation and Analysis of Factors Influencing Postsurgery Patient Satisfaction.

BACKGROUND: Most of the published literature addressing the satisfaction postinflatable penile implant (IPP) placement includes non-validated surveys. AIM: The study aims to report the survey outcomes of the English version of The QoLSPP and to evaluate the different factors that could influence these results. METHODS: Patients who underwent inflatable penile implant placement from January 2017 to December 2019 received a survey by phone and had a visit scheduled no sooner than 27 months after surgery. In the clinic, they were inquired about the penile size and underwent measurements of postoperative penile length and diameter. The survey responses were rated from zero to 5 following QoLSPP, and answers ≥3 were considered positive. An evaluation of the factors influencing the quality-of-life score of patients post-IPP placement was performed. Variables included age (<60, 60-70, >70), BMI classification, Charlson Comorbidity Index, diabetes diagnosis, implant type (AMS 700CX vs Titan), ED etiology, revisions, postoperative time in months (<30, 30-40, >40) and preoperative vs postoperative penile dimensions in those who attended the clinic. OUTCOMES: The primary outcome was to obtain accurate patient-reported satisfaction after inflatable penile implantation. RESULTS: Within the timeframe, 542 patients underwent first-time IPP placements. Of that group, 322(n) completed the surveys, and 109 patients attended the clinic to compare preoperative vs postoperative dimensions. Of note, 67 (61.4%) and 54 (49.4 %) demonstrated enlargement in length and diameter, respectively. Conversely, 12 (11%) and 4 (3.7%) experienced a shortening in length and girth. We found 66 (60.5%) patients who complained about a penile size decrease after the intervention. The survey had a positive response in 93.1% of the cases. There were no statistically significant differences in positive responses concerning the variables investigated. The subpopulation analysis of the penile-sized group neither showed response variations. CLINICAL IMPLICATIONS: The investigation allowed a better understanding of patient-reported satisfaction post-IPP placement. STRENGTHS & LIMITATIONS: The performance of all the procedures in a high-volume center by a single surgeon limits its generalization. CONCLUSION: The overall results after IPP surgery are positive in most patients who underwent the procedure and the variables investigated did not influence the overall outcomes of the QoLSPP survey in the study. Luna E, Rodriguez D, Barrios D, et al. Evaluation of Quality of Life After Inflatable Penile Implantation and Analysis of Factors Influencing Postsurgery Patient Satisfaction. J Sex Med 2022;19:1472-1478.

mpMRI-US Fusion-Guided Targeted Cryotherapy in Patients with Primary Localized Prostate Cancer: A Prospective Analysis of Oncological and Functional Outcomes.

Targeted therapy (TT) for prostate cancer (PCa) aims to ablate the malignant lesion with an adequate margin of safety in order to obtain similar oncological outcomes, but with less toxicity than radical treatments. The main aim of this study was to evaluate the recurrence rate (RR) in patients with primary localized PCa undergoing mpMRI/US fusion targeted cryotherapy (FTC). A secondary objective was to evaluate prostate-specific antigen (PSA) as a predictor of recurrences. We designed a prospective single-center single-cohort study. Patients with primary localized PCa, mono or multifocal lesions, PSA ≤ 15 ng/mL, and a Gleason score (GS) ≤ 4 + 3 undergoing FTC were enrolled. RR was chosen as the primary outcome. Recurrence was defined as the presence of clinically significant prostate cancer in the treated areas. PSA values measured at different times were tested as predictors of recurrence. Continuous variables were assessed with the Bayesian t-test and categorical assessments with the chix-squared test. Univariate and logistic regression assessment were used for predictions. A total of 75 cases were included in the study. Ten subjects developed a recurrence (RR: 15.2%), while fifty-six (84.8%) patients showed a recurrence-free status. A %PSA drop of 31.5% during the first 12 months after treatment predicted a recurrence with a sensitivity of 53.8% and a specificity of 79.2%. A PSA drop of 55.3% 12 months after treatment predicted a recurrence with a sensitivity of 91.7% and a specificity of 51.9%. FTC for primary localized PCa seems to be associated with a low but not negligible percentage of recurrences. Serum PSA levels may have a role indicating RR.

Permanent Deactivation of Inflatable Penile Prosthesis via Puncture.

OBJECTIVE: To describe our technique and early results for inflatable penile prosthesis (IPP) deactivation via puncture and drainage in the office setting to avoid penile explanting interventions in high-risk surgical patients. METHODS: A retrospective chart review of patients with high perioperative risk who had undergone IPP prosthesis puncture in the office setting between March 2020 and May 2021 was performed. Variables included age, the reason for penile prosthesis implantation and deactivation, time frame from implantation to deactivation, type of penile implant, follow-up time, and complications. Clinical information and procedural consent from patients with mental impairment were obtained from caretakers or legal guardians. RESULTS: In all the cases, the implants were in a good position and cycled well without difficulty before undergoing the drainage. Ten patients underwent the deactivation procedure, with ages ranging from 81 to 93 years old (mean 88 ± 3.74), 9 cases had a dementia diagnosis, and 1 case of penile implant aversion. Mean follow-up was 8.4 months ± 2.3, and there were no reported complications during the follow-up period. CONCLUSION: Permanent deactivation of IPP via in-office puncture and drainage represents a safe, feasible, and reliable option for those patients with multiple comorbidities and caretakers who desire removal of normally cycling, well-positioned, and uninfected penile implants. We strongly recommend all our patients with severe cognitive decline have their implants devices punctured to prevent any potential complications.

Molecular biomarkers in the context of focal therapy for prostate cancer: recommendations of a Delphi Consensus from the Focal Therapy Society.

BACKGROUND: Focal therapy (FT) for prostate cancer (PCa) is promising. However, long-term oncological results are awaited and there is no consensus on follow-up strategies. Molecular biomarkers (MB) may be useful in selecting, treating and following up men undergoing FT, though there is limited evidence in this field to guide practice. We aimed to conduct a consensus meeting, endorsed by the Focal Therapy Society, amongst a large group of experts, to understand the potential utility of MB in FT for localized PCa. METHODS: A 38-item questionnaire was built following a literature search. The authors then performed three rounds of a Delphi Consensus using DelphiManager, using the GRADE grid scoring system, followed by a face-to-face expert meeting. Three areas of interest were identified and covered concerning MB for FT, 1) the current/present role; 2) the potential/future role; 3) the recommended features for future studies. Consensus was defined using a 70% agreement threshold. RESULTS: Of 95 invited experts, 42 (44.2%) completed the three Delphi rounds. Twenty-four items reached a consensus and they were then approved at the meeting involving (N.=15) experts. Fourteen items reached a consensus on uncertainty, or they did not reach a consensus. They were re-discussed, resulting in a consensus (N.=3), a consensus on a partial agreement (N.=1), and a consensus on uncertainty (N.=10). A final list of statements were derived from the approved and discussed items, with the addition of three generated statements, to provide guidance regarding MB in the context of FT for localized PCa. Research efforts in this field should be considered a priority. CONCLUSIONS: The present study detailed an initial consensus on the use of MB in FT for PCa. This is until evidence becomes available on the subject.

The Role of Prostate-specific Membrane Antigen Positron Emission Tomography/Magnetic Resonance Imaging in Primary and Recurrent Prostate Cancer: A Systematic Review of the Literature.

CONTEXT: Prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) is a novel imaging technique with several potential applications in the prostate cancer (PCa) setting. OBJECTIVE: To perform a systematic review of the current evidence regarding the diagnostic performance of PSMA PET/MRI in patients with primary and recurrent PCa. EVIDENCE ACQUISITION: A comprehensive bibliographic search on the MEDLINE and Cochrane Library databases was performed in October 2020. The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Studies were deemed eligible if they assessed patients with primary or recurrent PCa (P) undergoing PSMA PET/MRI (I) with or without comparison with other imaging techniques (C) in order to evaluate its diagnostic performance (O). Retrospective and prospective primary clinical studies were included. Results of previous meta-analyses were reported. EVIDENCE SYNTHESIS: A total of 23 original articles and three meta-analyses were included. Limited evidence on PSMA PET/MRI is available, especially in the setting of partial gland ablation. PET/MRI can be an effective imaging modality for detecting primary PCa, showing higher accuracy than multiparametric MRI alone. It provides accurate local staging of primary PCa; however, there are contradictory results in this context when its performance is compared with other imaging techniques. PET/MRI also shows high performance for restaging and detecting tumor recurrence, even at low prostate-specific antigen levels. CONCLUSIONS: PSMA PET/MRI could represent a valuable tool in the management of patients with primary and recurrent PCa. No specific recommendations can be provided. PATIENT SUMMARY: Encouraging data regarding the benefits of prostate-specific membrane antigen positron emission tomography/magnetic resonance imaging in patients with prostate cancer are emerging from the literature.

Feasibility of in-office MRI-targeted partial gland cryoablation for prostate cancer: an IDEAL stage 2A study.

OBJECTIVES: Cryoablation for prostate cancer is typically performed under general anaesthesia. We explore the safety, feasibility and costs of in-office MRI-targeted prostate partial gland cryoablation (PGC) under local anaesthesia. We hypothesise that an office-based procedure under local anaesthesia may yield greater patient convenience and lower health costs with similar outcomes to a general anaesthesia approach. DESIGN/PARTICIPANTS/SETTING/INTERVENTIONS: Retrospective study of men diagnosed with clinically significant prostate cancer (grade group (GG) ≥2) who elected to undergo in-office PGC under local anaesthesia. MAIN OUTCOME MEASURES: A total of 55 men with GG ≥2 prostate cancer underwent PGC under local anaesthesia, and 35 of 43 men (81.4%) who attained ≥6 months of follow-up post-treatment underwent MRI-targeted surveillance biopsy. We used MRI findings and targeted biopsy to characterise post-PGC oncological outcomes. Complications were categorised using Common Terminology Criteria for Adverse Events (CTCAE). Expanded Prostate Cancer Index-Clinical Practice was used to characterise urinary and sexual function scores at baseline, 4 and 9 months post-PGC. Time-driven activity-based costing was used to determine healthcare costs of in-office PGC. RESULTS: Five (9.1%) men experienced CTCAE score 3 adverse events. Urinary and sexual function did not change significantly from baseline to 4 months (p=0.20 and p=0.08, respectively) and 9 months (p=0.23 and p=0.67, respectively). Twenty-two men (62.9%) had no cancer or GG1 and 13 (37.1%) men had GG≥2 on post-PGC biopsy. Moreover, the median cost of in-office PGC was US$4,463.05 (range US$4,087.19-US7,238.16) with disposables comprising 69% of the cost. CONCLUSIONS: In-office PGC is feasible under local anaesthesia with favourable functional outcome preservation and adverse events profile at significantly lower costs compared with a general anaesthesia approach.

Clinical Utility of a Genomic Classifier in Men Undergoing Radical Prostatectomy: The PRO-IMPACT Trial.

PURPOSE: The optimal management of men with prostate cancer at high risk of recurrence postradical prostatectomy is controversial. The clinical utility of the Decipher test was evaluated prospectively on postoperative treatment decisions and patient-reported outcomes. METHODS AND MATERIALS: In the study, 246 eligible men across 19 centers were enrolled. Patients were dichotomized into those considering adjuvant or salvage radiation therapy (ART or SRT). Participating providers submitted a management recommendation before and after receiving the Decipher test results. Treatment received within 12 months and a validated survey on prostate cancer-related anxiety were collected longitudinally. RESULTS: Pre-Decipher, treatment was recommended for 12% and 40% for the ART and SRT arms, respectively. Post-Decipher, 17% and 30% of treatment recommendations changed in the ART and SRT arms, respectively. Post-Decipher treatment recommendation was administered 78% and 76% of the time in the ART and SRT arms, respectively. Multivariable analysis confirmed that the Decipher score was an independent predictor for change in management for both adjuvant and salvage patients. The number needed to test to change management for one patient was 4. Cancer-specific anxiety decreased among Decipher risk categories in both arms. CONCLUSIONS: Use of Decipher postradical prostatectomy test was associated with postoperative treatment decisions. Overall, high Decipher risk was associated with an increase in treatment intensity whereas low risk scores were associated with a decrease in therapy administered independent of clinical and pathologic risk factors.

Definitive and sustained increase in prostate cancer metastases in the United States.

INTRODUCTION: We examined the most recent Surveillance, Epidemiology, and End Results release to corroborate temporal trends in nonmetastatic and distant prostate cancer metastases in the United States. METHODS: Surveillance, Epidemiology, and End Results was analyzed for the incidence of nonmetastatic and distant metastasis for men with prostate cancer aged 50-74 and ≥75 years during 2004-2015. Incidence ratios (IR) were calculated relative to the year prior. RESULTS: The incidence of distant metastasis significantly increased from 451.0 to 504.0 per million (IR:1.12, 95% CI:1.01-1.24) from 2011 to 2012 and 532.3 to 586.1 per million (IR:1.10, 95% CI:1.00-1.21) from 2014 to 2015 in men aged ≥75 years. The incidence of distant metastasis did not significantly increase in men aged 55-74 over the study period. CONCLUSION: We demonstrate a sustained and definitive increase in prostate cancer distant metastases in men aged ≥75 years. Although our observational study design cannot pinpoint the exact cause of this increase, which is likely multifactorial, this shift reverses declines in metastases at diagnoses that followed the advent of prostate-specific antigen screening.

SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer.

PURPOSE: The SPARED CRN (Study of Prostate Ablation Related Energy Devices Coordinated Registry Network) is a private-public partnership between academic and community urologists, the FDA (U.S. Food and Drug Administration), the Medical Device Epidemiology Network and device manufacturers to examine the safety and effectiveness of technologies for partial gland ablation in men with localized prostate cancer. MATERIALS AND METHODS: We report on a recent workshop at the FDA with thought leaders to discuss a critical framework for partial gland ablation, focusing on patient selection, surgical planning, followup, study design and appropriate comparators in terms of adverse events and cancer control outcomes. We summarize salient points from experts in urology, oncology and epidemiology that were presented and discussed in an open forum. RESULTS: Given the challenges in achieving patient and physician equipoise to perform a randomized trial, as well as an inherent paradigm shift when comparing partial gland ablation (inability to assess prostate specific antigen recurrence) to whole gland treatments, the group focused on objective performance criteria and goals as a platform to guide the creation of single arm studies in the SPARED CRN. CONCLUSIONS: This summit lays the foundation for prospective, multi-center data collection and evaluation of novel medical devices and drug/device combinations for partial gland ablation.

Effect of operative local anesthesia on postoperative pain outcomes of inflatable penile prosthesis: prospective comparison of two medications.

Few studies have examined the roles of dorsal penile nerve block (DPNB) and penile ring block (PRB) in surgery of inflatable penile prosthesis (IPP) placement. We sought to compare the postoperative pain outcomes of two different medications used in DPNB plus PRB. We thus carried out a prospective study of patients with erectile dysfunction who underwent "de novo" IPP placement between January 2013 and June 2013. Patients were divided to one of three groups: 1-DPNB plus PRB with bupivacaine injection; 2-DPNB plus PRB with ropivacaine injection and, 3-Control group without DPNB or PRB injection. Postoperative pain score and pain medication usage were recorded 2 h postoperatively, and every 24 h, for a week. The Visual Analog Scale (VAS) was used as pain scale measurement. A total of 131 patients were included in this study: 40 to bupivacaine, 47 to ropivacaine, and the rest were controls. Two hours postoperatively, mean VAS was significantly different (p < 0.0001) between medicated patients and the control group, however, no significant differences were observed between medication groups. Mean VAS was not significantly different among the groups from post-surgical day 2 thru 7. In conclusion, DPNB plus PRB during IPP provided effective analgesia in the immediate post-operative recovery.

New technologies and techniques for prostate cancer focal therapy.

INTRODUCTION: The aim of this study was to review the oncological and functional outcomes of new and established primary focal treatments (FT) for localized prostate cancer (PCa). EVIDENCE ACQUISITION: We performed a systematic search of published studies on FT for localized PCa using electronic databases (Medline and Embase). These studies included reports on hemi-ablation, focal ablation and target-ablation. We excluded salvage focal therapy studies and limited the search to those with a minimum of 12 months of follow-up. EVIDENCE SYNTHESIS: We selected 20 studies with a total of 2523 patients who were treated in the primary setting. The energy sources used were cryotherapy (8), high-intensity focused ultrasound (9), irreversible electroporation (1), photodynamic therapy (1) and focused laser ablation (1), with 65% hemiablation, 25% focal ablation and 10% target-ablation. The median follow-ups ranged from 6 to 44.4 months. Mean age was 60.4-70 years and mean prostate-specific antigen was 4.4-<10 ng/dL; 26-100% had a Gleason Score of 6, and 0-65% had a Gleason Score of 7. Patient selection was carried out by TRUS biopsy in 9 studies, while transperineal template mapping biopsy and mp-MRI were employed in six and 13 studies, respectively. The overall post-treatment positive biopsy rate was 1.2-51% with 1.6-32% patients having a residual disease in the treated area. The post-treatment continence rates were 90-100%, and the rates of erectile dysfunction ranged from 0-53.2%. CONCLUSIONS: Reliable evidence for the partial-gland treatment of PCa is increasing, and encouraging mid-term oncologic outcomes with the preservation of sexual and urinary functions have been reported. Accurate patient selection at the outset of treatment and careful follow-up seem key attributes to achieve excellent functional results and encouraging oncological outcomes.