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.

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.

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.

Decipher test impacts decision making among patients considering adjuvant and salvage treatment after radical prostatectomy: Interim results from the Multicenter Prospective PRO-IMPACT study.

BACKGROUND: Patients with prostate cancer and their providers face uncertainty as they consider adjuvant radiotherapy (ART) or salvage radiotherapy (SRT) after undergoing radical prostatectomy. The authors prospectively evaluated the impact of the Decipher test, which predicts metastasis risk after radical prostatectomy, on decision making for ART and SRT. METHODS: A total of 150 patients who were considering ART and 115 who were considering SRT were enrolled. Providers submitted a management recommendation before processing the Decipher test and again at the time of receipt of the test results. Patients completed validated surveys on prostate cancer (PCa)-specific decisional effectiveness and PCa-related anxiety. RESULTS: Before the Decipher test, observation was recommended for 89% of patients considering ART and 58% of patients considering SRT. After Decipher testing, 18% (95% confidence interval [95% CI], 12%-25%) of treatment recommendations changed in the ART arm, including 31% among high-risk patients; and 32% (95% CI, 24%-42%) of management recommendations changed in the salvage arm, including 56% among high-risk patients. Decisional Conflict Scale (DCS) scores were better after viewing Decipher test results (ART arm: median DCS before Decipher, 25 and after Decipher, 19 [P<.001]; SRT arm: median DCS before Decipher, 27 and after Decipher, 23 [P<.001]). PCa-specific anxiety changed after Decipher testing; fear of PCa disease recurrence in the ART arm (P = .02) and PCa-specific anxiety in the SRT arm (P = .05) decreased significantly among low-risk patients. Decipher results reported per 5% increase in 5-year metastasis probability were associated with the decision to pursue ART (odds ratio, 1.48; 95% CI, 1.19-1.85) and SRT (odds ratio, 1.41; 95% CI, 1.09-1.81) in multivariable logistic regression analysis. CONCLUSIONS: Knowledge of Decipher test results was associated with treatment decision making and improved decisional effectiveness among men with PCa who were considering ART and SRT. Cancer 2017;123:2850-59. © 2017 American Cancer Society.

Experience With Prophylactic Gentamicin During Penile Prosthesis Surgery: A Retrospective Comparison of Two Different Doses.

BACKGROUND: Gentamicin has been determined to be active against a wide range of bacterial infections and has been commonly used as a preoperative antibiotic for inflatable penile prosthesis (IPP) implantation. However, the best dosing regimen to produce the safest optimal prophylactic effect remains to be determined. AIM: To compare low- and high-dose gentamicin as prophylaxis during IPP implantation. METHODS: We retrospectively analyzed two groups of patients who underwent IPP placement from April 14, 2012 through April 13, 2016. Group 1 was composed of 490 patients who underwent IPP placement from April 14, 2012 through April 13, 2014 and received a low dose of preoperative gentamicin at 80 mg every 8 hours for 1 day. Group 2 was composed of 407 patients who underwent IPP placement from April 14, 2014 through April 13, 2016 and received a single high dose of preoperative gentamicin at 5 mg/kg. We compared the infection rates of IPP and any gentamicin-related toxicities. The same surgeon performed all procedures. All patients received additional vancomycin 1 g before incision and at 12 hours postoperatively. OUTCOME: Demographic data and IPP infection rate were compared and potential toxicities from the higher dose of gentamicin were closely monitored. RESULTS: There were no significant differences in mean age, mean body mass index, and mean interval for IPP placement and IPP infection between the two groups. No toxicity was seen with the higher gentamicin dose. Six cases in group 1 (five de novo cases and one redo case, infection rate = 1.22%) and three cases in group 2 (two de novo cases and one redo case, infection rate = 0.74%) were found to have IPP infection. The infection rate in group 2 appeared to be lower than that in group 1, although a significant statistical difference was not achieved (P = .057). CLINICAL IMPLICATIONS: These findings would help guide urologists in choosing an optimal preoperative gentamicin dose for IPP surgery. STRENGTHS AND LIMITATIONS: This is the first study to report on the usage of high-dose preoperative gentamicin for IPP surgery but with limitations as a retrospective study. CONCLUSIONS: Although not achieving a statistical difference, there was a trend for patients receiving a higher dose of preoperative gentamicin to have a lower IPP infection rate. No toxicity was encountered from the 5-mg/kg gentamicin dose. We recommend following prophylactic high-dose gentamicin guidelines. Xie D, Gheiler V, Lopez I, et al. Experience With Prophylactic Gentamicin During Penile Prosthesis Surgery: A Retrospective Comparison of Two Different Doses. J Sex Med 2017;14:1160-1164.

Impact of the Cell Cycle Progression Test on Physician and Patient Treatment Selection for Localized Prostate Cancer.

PURPOSE: The cell cycle progression test is a validated molecular assay that assesses prostate cancer specific disease progression and mortality risk when combined with clinicopathological parameters. We present the results from PROCEDE-1000, a large, prospective registry designed to evaluate the impact of the cell cycle progression test on shared treatment decision making for patients newly diagnosed with prostate cancer. MATERIALS AND METHODS: Untreated patients with newly diagnosed prostate adenocarcinoma were enrolled in the study and the cell cycle progression test was performed on the initial prostate biopsy tissue. A set of 4 sequential surveys tracked changes relative to initial therapy recommendations (before cell cycle progression) based on clinicopathological parameters following physician review of the cell cycle progression test result, physician/patient review of the cell cycle progression test results and a minimum of 3 months of clinical followup (actual treatment). RESULTS: Of the 1,596 patients enrolled in this registry 1,206 were eligible for analysis. There was a significant reduction in the treatment burden recorded at each successive evaluation (p <0.0001), with the mean number of treatments per patient decreasing from 1.72 before the cell cycle progression test to 1.16 in actual followup. The cell cycle progression test caused a change in actual treatment in 47.8% of patients. Of these changes 72.1% were reductions and 26.9% were increases in treatment. For each clinical risk category there was a significant change in treatment modality (intervention vs nonintervention) before vs after cell cycle progression testing (p=0.0002). CONCLUSIONS: The cell cycle progression test has a significant impact in assisting physicians and patients reach personalized treatment decisions.

A randomized, double-blind, solifenacin succinate versus placebo control, phase 4, multicenter study evaluating urinary continence after robotic assisted radical prostatectomy.

PURPOSE: Bladder dysfunction influences recovery of urinary continence after radical prostatectomy. We performed a multicenter, randomized, double-blind study evaluating solifenacin vs placebo on return to continence in patients who were still incontinent 7 to 21 days after catheter removal after robot-assisted radical prostatectomy. MATERIALS AND METHODS: A wireless personal digital assistant was given to patients the day of catheter removal. Encrypted answers were transmitted daily to dedicated servers. After a 7 to 21-day treatment-free washout period, patients requiring 2 to 10 pads per day for 7 consecutive days were randomized (1:1) to 5 mg solifenacin daily or placebo. The primary end point was time from first dose to continence defined as 0 pads per day or a dry security pad for 3 consecutive days. Secondary end points included proportion of patients continent at end of study, average change in pads per day number and quality of life assessments. RESULTS: A total of 1,086 screened patients recorded personal digital assistant information. Overall 640 patients were randomized to solifenacin vs placebo and 17 failed to take medication. There was no difference in time to continence (p=0.17). Continence was achieved by study end in 91 of 313 (29%) vs 66 of 309 (21%), respectively (p=0.04). Pads per day change from baseline was -3.2 and -2.9, respectively (p=0.03). Dry mouth was the only common adverse event seen in 6.1% and 0.6%, respectively. Constipation rates were similar. The overall rate of continence in the entire population from screening to end of study was 73%. CONCLUSIONS: There was no effect on primary outcome but some secondary end points benefited the solifenacin arm. The study provides level 1B clinical evidence for continence outcomes after robot-assisted radical prostatectomy.

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.

Oncocytoma of the adrenal gland medulla.

We report an unprecedented case of an oncocytoma of the adrenal gland medulla in a 61-year-old woman. The patient presented with right flank pain and hematuria. Computed tomographic studies revealed a right adrenal gland mass that measured 2 cm, which was subsequently excised laparoscopically. Grossly, the tumor in the medulla measured 1.9 × 1.2 cm, weighed 5 g, and had a solid tan-brown cut surface. Histologically, it consisted of large tumor cells containing eosinophilic granular cytoplasm arranged in trabecular and nodular patterns. Electron microscopy revealed closely packed mitochondria in the cytoplasm of almost all tumor cells. The tumor cells were immunohistochemically positive for vimentin. The patient resumed usual activities 2 weeks after surgery, and at 6-month follow-up, she is doing well.

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.

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.

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.

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.

Surgery confounds biology: the predictive value of stage-, grade- and prostate-specific antigen for recurrence after radical prostatectomy as a function of surgeon experience.

Statistical models predicting cancer recurrence after surgery are based on biologic variables. We have shown previously that prostate cancer recurrence is related to both tumor biology and to surgical technique. Here, we evaluate the association between several biological predictors and biochemical recurrence across varying surgical experience. The study included two separate cohorts: 6,091 patients treated by open radical prostatectomy and an independent replication set of 2,298 patients treated laparoscopically. We calculated the odds ratios for biological predictors of biochemical recurrence-stage, Gleason grade and prostate-specific antigen (PSA)-and also the predictive accuracy (area under the curve, AUC) of a multivariable model, for subgroups of patients defined by the experience of their surgeon. In the open cohort, the odds ratio for Gleason score 8+ and advanced pathologic stage, though not PSA or Gleason score 7, increased dramatically when patients treated by surgeons with lower levels of experience were excluded (Gleason 8+: odds ratios 5.6 overall vs. 13.0 for patients treated by surgeons with 1,000+ prior cases; locally advanced disease: odds ratios of 6.6 vs. 12.2, respectively). The AUC of the multivariable model was 0.750 for patients treated by surgeons with 50 or fewer cases compared to 0.849 for patients treated by surgeons with 500 or more. Although predictiveness was lower overall for the independent replication set cohort, the main findings were replicated. Surgery confounds biology. Although our findings have no direct clinical implications, studies investigating biological variables as predictors of outcome after curative resection of cancer should consider the impact of surgeon-specific factors.

Posterior rhabdosphincter reconstruction during robotic assisted radical prostatectomy: results from a phase II randomized clinical trial.

PURPOSE: Posterior rhabdosphincter reconstruction following radical prostatectomy was designed to improve early urinary continence. We executed a randomized clinical trial to test this conjecture in men undergoing robotic radical prostatectomy. MATERIALS AND METHODS: We conducted a phase II randomized clinical trial intended to detect a 25% difference in 3-month continence outcomes defined by a patient response of 0 or 1 to question 5 of the Expanded Prostate Cancer Index Composite questionnaire urinary domain, comparing standard running vesicourethral anastomosis (controls) to posterior rhabdosphincter reconstruction followed by standard running vesicourethral anastomosis (posterior rhabdosphincter reconstruction treated). Patients had clinically localized prostate cancer and were blinded. Surgeons were notified of computer randomization after prostate excision. Further continence outcomes were assessed by analysis of Expanded Prostate Cancer Index Composite questionnaire questions 1 and 12, International Prostate Symptom Score and 24-hour pad weights. Statistical significance was defined as p <0.05 RESULTS: A total of 94 patients were randomized, 47 to each arm. Preoperative clinical and functional variables were equivalent between study arms. There were no complications associated with either anastomotic technique. Of the 87 evaluable patients 62 (71.3%) met our 3-month continence definition. The null hypothesis was not rejected as 33 (81%) controls and 29 (63%) posterior rhabdosphincter reconstruction treated patients were continent at 3 months (chi-square p = 0.07, Fisher exact p = 0.1). Likewise there was no significant difference between arms in 24-hour pad weights (p = 0.14), International Prostate Symptom Score (p = 0.4), absence of daily leaks (p = 0.4) or perception of urinary function (p = 0.4). CONCLUSIONS: In this randomized clinical trial posterior rhabdosphincter reconstruction offered no advantage for return of early continence after robotic assisted radical prostatectomy.

Robotic radical prostatectomy: present and future.

The last 10 years have witnessed unprecedented evolution regarding de surgical removal of the prostate gland. Laparoscopic radical prostatectomy broke the open paradigm and started to generate great excitement and expectations. Shortly however, robot-assisted, laparoscopic - Robotic Surgery - emerged to address a fundamental pitfall of prostate laparoscopic surgery: execution reproducibility. Today, robotic assisted laparoscopic prostatectomy is the most used surgical approach to remove the prostate gland. Consistent advantages of this technique are: a shorter convalescent state, marked decrease in blood loss and in experienced hands, shorter average surgical times. Importantly it served to highlight the importance of outcomes as ultimate judge of a procedure success. The data suggest equivalency in long-term functional and oncological outcomes, while clear advantages in the short run: perioperative outcomes with patient rapid return to productive state. That said, the major challenge for robotic surgeons still remains: establish a paradigm that breaks with the tradition and prevents biased reporting due to technology and marketing enthusiasm, but rather takes a critical approach based in prospective, controlled, randomize clinical trials. If the latter objective is reached, urologic robotic surgeons will deliver counseling based on clinical evidence delivering major progress for our Urology field.