A Description and Safety Overview of Irreversible Electroporation for Prostate Tissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial.

The PRESERVE study (NCT04972097) aims to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa). The NanoKnife uses irreversible electroporation (IRE) to deliver high-voltage electrical pulses to change the permeability of cell membranes, leading to cell death. A total of 121 subjects with organ-confined PCa ≤ T2c, prostate-specific antigens (PSAs) ≤ 15 ng/mL, and a Gleason score of 3 + 4 or 4 + 3 underwent focal ablation of the index lesion. The primary endpoints included negative in-field biopsy and adverse event incidence, type, and severity through 12 months. At the time of analysis, the trial had completed accrual with preliminary follow-up available. Demographics, disease characteristics, procedural details, PSA responses, and adverse events (AEs) are presented. The median (IQR) age at screening was 67.0 (61.0-72.0) years and Gleason distribution 3 + 4 (80.2%) and 4 + 3 (19.8%). At 6 months, all patients with available data (n = 74) experienced a median (IQR) percent reduction in PSA of 67.6% (52.3-82.2%). Only ten subjects (8.3%) experienced a Grade 3 adverse event; five were procedure-related. No Grade ≥ 4 AEs were reported. This study supports prior findings that IRE prostate ablation with the NanoKnife System can be performed safely. Final results are required to fully assess oncological, functional, and safety outcomes.

Validation of new AJCC exclusion criteria for subepithelial prostatic stromal invasion from pT4a bladder urothelial carcinoma.

PURPOSE: In 2010 the AJCC (American Joint Committee on Cancer) excluded urothelial carcinoma with subepithelial prostatic stromal invasion from the pT4a bladder cancer staging class, which is otherwise defined by direct prostatic invasion transmurally from the bladder. We determined if the new guidelines were reflective of differences in survival between subepithelial prostatic stromal invasion and transmural pT4a disease. MATERIALS AND METHODS: A retrospective, multi-institutional cohort of cystectomy cases with subepithelial prostatic stromal invasion from the University of Chicago and Cleveland Clinic were compared to a cohort with transmural pT4a disease. All pathological specimens were rereviewed at the respective institutions. Patients were excluded from the final cohort if variant bladder cancer histology, pT3 bladder disease or extraprostatic extension of urothelial carcinoma were identified. The primary end points were cancer specific and overall survival. RESULTS: Our study sample consisted of 48 patients with subepithelial prostatic stromal invasion and 49 patients with transmural pT4a disease. Median followup was 12.8 months (IQR 4.9 to 31.4). Patients with subepithelial prostatic stromal invasion had lower rates of lymph node involvement than those with transmural pT4a disease (14.6% vs 61.2%, p <0.001) and lower rates of positive surgical margins (18.7% vs 61.2%, p <0.001). Rates of perioperative chemotherapy were similar in both groups. When comparing subepithelial prostatic stromal invasion and transmural pT4a groups, overall survival was 64.0 vs 9.8 months and median cancer specific survival was not achieved vs 16.5 months, respectively (p <0.001). CONCLUSIONS: Subepithelial prostatic stromal invasion from urothelial carcinoma has more favorable outcomes compared to transmural pT4a disease. Our results support the exclusion of subepithelial prostatic stromal invasion from the pT4a bladder urothelial carcinoma staging class.

Comparative outcomes of laparoscopic and open adrenalectomy for adrenocortical carcinoma: single, high-volume center experience.

PURPOSE: Adrenocortical carcinoma (ACC) is a rare and clinically aggressive cancer. Previous studies reported increased recurrence rates associated with laparoscopic adrenalectomy (LA). We evaluated a single-center experience of LA versus open adrenalectomy (OA) for the management of ACC. METHODS: Between 1993 and 2011, 44 consecutive patients with primary ACC were treated at our institution. Baseline patient characteristics and surgical and pathological outcomes were compared between OA and LA groups. Multivariable Cox proportional hazards analysis was used to estimate the association between OA versus LA with recurrence-free and overall survival. RESULTS: Eighteen and 26 patients underwent LA and OA, respectively. Patients who underwent OA had larger tumors and more advanced clinical stage compared with LA group. During a median follow-up of 22 months, 22 recurrences and 26 deaths were observed. The 2-year, recurrence-free and overall survivals for OA and LA were 60 vs. 39 % (P = 0.7) and 54 vs. 58 % (P = 0.6), respectively. After adjusting for clinical stage, OA was associated with lower risk of recurrence (hazard ratio (HR) 0.4; 95 % confidence interval (CI) 0.2-1.2; P = 0.099) and improved overall survival (HR 0.5; 95 % CI 0.2-1.2; P = 0.122) compared with LA, although differences were not statistically significant. CONCLUSIONS: A nonstatistically significant increase in recurrence and death was observed among patients undergoing LA versus OA after adjusting for clinical stage. The rarity of this disease limits the ability to assess for significant differences in a single-institution series. Patients with suspected ACC should be considered for OA.

Presacral and retroperitoneal lymph node involvement in urothelial bladder cancer: results of a prospective mapping study.

PURPOSE: We evaluated the incidence of positive lymph nodes in the presacral and retroperitoneal regions in patients who underwent radical cystectomy and extended pelvic lymph node dissection for urothelial bladder cancer. MATERIALS AND METHODS: As part of a prospective mapping study, 143 patients underwent radical cystectomy and extended pelvic lymph node dissection for urothelial bladder cancer between 2006 and 2010. Lymph nodes from 6 separate regions were labeled, including bilateral pelvic and common iliac, presacral and retroperitoneal. We evaluated pathological features, treatment outcomes and cancer specific survival in patients with or without lymph node positive disease in the presacral and retroperitoneal regions. RESULTS: A median of 37 lymph nodes (IQR 27-49) were removed. Overall 52 (36%) patients had positive lymph nodes, of whom 24 (46%) had metastatic disease in the presacral or retroperitoneal region. Four patients (3%) had an isolated solitary positive lymph node in these 2 templates. Two-year overall survival in patients without vs with presacral/retroperitoneal lymph node positive disease was 44% (95% CI 24-64) vs 25% (95% CI 5-45) (p = 0.11). In contrast, 2-year cancer specific survival in the 2 groups was 55% (95% CI 33-77) and 29% (95% CI 7-51), respectively (p = 0.02). CONCLUSIONS: A substantial proportion of patients have lymph node positive disease in the presacral and retroperitoneal regions, including some with isolated and/or solitary lymph node involvement. While the limited positive lymph node burden in these templates suggests a potential therapeutic role for extending the anatomical boundaries of lymph node dissection, patient survival was poor. Extended lymph node dissection provides important staging information but to our knowledge the therapeutic benefit has yet to be definitively proved.

Prevention and treatment of transitional cell carcinomatosis with intraperitoneal chemotherapy in a rat model.

PURPOSE: Tumor spillage from bladder perforation during transurethral bladder tumor resection or cystectomy risks seeding the peritoneum with transitional cell carcinoma. We determined the lowest effective mitomycin C dose to prevent tumor implantation and the potential efficacy of delayed therapy. Additionally, we investigated the effect of tumor debulking combined with intraperitoneal mitomycin C. MATERIALS AND METHODS: Using our established murine model of intraperitoneal transitional cell carcinoma implantation mitomycin C was instilled at decreasing concentrations to find the lowest effective dose. To evaluate the effectiveness of delayed therapy mitomycin C was administered on day 3 or 7 after tumor implantation. Finally, surgical debulking of established tumors with or without mitomycin C was performed. RESULTS: All control animals had disseminated carcinomatosis. The lowest effective intraperitoneal mitomycin C dose to prevent implantation was 0.3125 mg/m(2). Administration of mitomycin C on day 3 after instillation resulted in tumor-free status in 50% of the animals, although no rats were tumor-free when treated on day 7. Tumor debulking only for established disease cured 40% of the animals, whereas debulking combined with mitomycin C had a 100% cure rate. CONCLUSIONS: Intraperitoneal mitomycin C prevents tumor growth after transitional cell carcinoma implantation. Delayed therapy is not as effective as immediate treatment but cure is still possible, particularly when combined with surgical debulking, in a rat model.

In vivo and in vitro effect of baicalein on human prostate cancer cells.

We investigated the in vitro effects of baicalein and baicalin on human umbilical vein endothelial cells (HUVECs) and on human prostate tumor cells (DU-145 and PC3) as well as the effect of orally administered baicalein on the growth of DU-145 cells after subcutaneous injection into SCID mice. In vitro effects of baicalein and baicalin treatment on human prostate cancer cell lines DU-145 and PC-3 were assessed by employing cell proliferation (MTS) assay, cytotoxicity (LIVE/DEAD) assay, and TUNEL assay. In vitro anti-proliferative and anti-angiogenic properties of baicalein and baicalin were studied on HUVECs by sprout assay. The effect of orally administered baicalein on tumor growth in SCID mice was studied in four groups (n=10) of animals injected subcutaneously with DU-145 cells and treated daily for 28 days. The control group received only vehicle (carboxymethylcellulose), whereas the other three groups received escalating doses of baicalein (10, 20, and 40 mg/kg per day). Baicalein and baicalin exhibit dose-dependent growth inhibitory effects on human prostate cancer cells and umbilical vein endothelial cells in vitro. Also, treatment by these two flavonoid compounds significantly decreased the average number and length of sprouts formed by the endothelial cell aggregates in a dose-dependent manner. In vivo, treatment of mice with baicalein demonstrated a statistically significant tumor volume reduction (p<0.01) when compared to the control. This is the first study demonstrating an in vivo growth inhibitory effect of orally administered baicalein on human prostate tumors in mice.

Concurrent Testicular and Bladder Cancer in a 57-year-old Man.

We present a rare finding of concurrent right testis non-seminomatous mixed germ cell tumor and muscle invasive urothelial carcinoma of the bladder in a 57-year-old homeless man. The socioeconomic factors and the disease presentation caused a treatment dilemma in terms of the appropriate type of neoadjuvant chemotherapy. The patient ultimately underwent upfront surgery with retroperitoneal lymph node dissection and radical cystoprostatectomy followed by adjuvant cisplatin-based chemotherapy.

CD117⁺ cells in the circulation are predictive of advanced prostate cancer.

Circulating tumor cells (CTCs) are associated with cancer progression, aggressiveness and metastasis. However, the frequency and predictive value of CTCs in patients remains unknown. If circulating cells are involved in tumor aggressiveness and metastasis, then cell levels should decline upon tumor removal in localized cancer patients, but remain high in metastatic patients. Accordingly, proposed biomarkers CD117/c-kit, CD133, CXCR4/CD184, and CD34-positive cell percentages in the blood of patients undergoing radical prostatectomy for localized cancer were assessed by flow cytometry prior to intervention and 1-3 months postoperatively. Only circulating CD117⁺ cell percentages decreased after radical prostatectomy, increased with cancer progression and correlated with high PSA values. Notably, postoperative CD117⁺ levels did not decrease in patients experiencing biochemical recurrence. In a xenograft model, CD117-enriched tumors were more vascularized and aggressive. Thus, CD117 expression on CTCs promotes tumor progression and could be a biomarker for prostate cancer diagnosis, prognosis, and/or response to therapy.

Active surveillance for low-risk prostate cancer in African American men: a multi-institutional experience.

OBJECTIVE: To compare the outcomes of active surveillance (AS) series between African American men (AAM) and non-AAM diagnosed with low-risk prostate cancer at 3 medical centers. METHODS: Between 2005 and 2012, 214 men accepted AS on the basis of favorable clinical features and parameters after initial and repeat biopsy. Failure was defined as increase in Gleason score >6, total positive cores >33%, maximum cancer volume in any core >50%, or a prostate-specific antigen >10 ng/mL. Disease progression and overall AS failure were compared between the 2 groups. RESULTS: Of 214 men, 75 were excluded, leaving 67 AAM and 72 non-AAM on AS. Median age at diagnosis was 64 and 67 years for AAM and non-AAM, respectively, and median follow-up was 34 and 46 months, respectively. During this time, 44 AAM (66%) remained on AS, and 23 (34%) underwent treatment, of whom 6 (26%) were treated by patient choice and 17 (74%) because of disease progression. In the non-AAM group, 59 (82%) men remained on AS, and 13 (18%) underwent treatment, 8 (62%) were treated by patient choice and 5 (38%) because of disease progression. The 3-year freedom from overall treatment was 74% and did not differ by race (P = .06). The 3-year freedom from disease progression was 85%, where AAM were at significantly higher risk of disease progression (hazard ratio = 3.8; 95% confidence interval: 1.4-10.4; P = .01). CONCLUSION: Our study suggests a higher disease progression rate in AAM who choose AS for low-risk prostate cancer compared with non-AAM, signifying a potential need for closer follow-up and more stringent enrollment criteria in AAM.

Severe penile injuries in children and adolescents: reconstruction modalities and outcomes.

OBJECTIVE: To review our experience with severe penile trauma, mechanism of injury, and their treatment modalities in 16 children younger than 18 years. Management of penile trauma poses diverse challenges to the reconstructive urologist, as injuries vary from abrasions to total emasculation. METHODS: Analysis of 16 patients with severe penile injuries referred to us between 2002 and 2011 was undertaken. The median age at surgery was 13 years (range, 5-17). Etiology of penile trauma and choice of treatment were evaluated. The management included a wide variety of surgical techniques that were tailored to the individual patient. Results were analyzed to define etiology, that is, mechanism of penile injury and to estimate modalities of surgical management and postoperative outcomes. Also, postoperative questionnaire was used, which included questions on functioning and esthetical appearance of participating patients and overall satisfaction. RESULTS: The causes of penile injury in these series were traffic accidents (2), iatrogenic trauma (5), self-amputation (1), electrocution (1), burns (3), dog bite (2), zipper injury (1), and mother's hair strangulation (1). The mean follow-up was 46 months (range, 14-122), and examinations were uneventful, except for 2 fistulae formation after neophallic urethral reconstruction. CONCLUSION: The main goal of reconstructive surgery is to have a penis with normal appearance and functions. Severe penile injuries should be treated on a case-by-case basis using the most propitious techniques.

Utility of intraoperative frozen section during robot-assisted partial nephrectomy: a single institution experience.

BACKGROUND AND PURPOSE: Intraoperative frozen section (FS) analysis has been regarded as a paramount tool for immediate evaluation of tumor margin status during partial nephrectomy procedures. The aim of this study was to assess the utility of FS during robot-assisted partial nephrectomy (RAPN). PATIENTS AND METHODS: A retrospective review of our Institutional Review Board-approved prospectively maintained minimally invasive partial nephrectomy database yielded 342 consecutive RAPN procedures from June 2007 to September 2011. Of these, the initial 128 cases underwent FS evaluation, whereas the following 214 cases did not. Patient demographics, perioperative outcomes, and final pathology results were analyzed and compared between the two groups. RESULTS: Body mass index, Charleson Comorbidity Index, tumor size, renal score, preoperative creatinine level, and estimated glomerular filtration rate (eGFR) were similar between both groups. Operative time was significantly longer in the no-FS group (193 vs 180 min; P=0.04). Warm ischemia time (median 19 vs 19 min), estimated blood loss (150 vs 200 mL), postoperative creatinine level (1.0 vs 1.1 mg/dL), and postoperative eGFR (75.6 vs 75.9) were similar between the no-FS group and FS group, respectively. Complications occurred in 32 (15.0%) and 31 (24.2%) cases in no-FS and FS, respectively (P=0.06). Final pathology results demonstrated seven cases of positive margins, 1 (1%), in the FS group and 6 (3%) in the no-FS group (P=0.19). Of the cases with positive margins at final pathology analysis, a R.E.N.A.L. score of 3/3 was found on closeness to renal sinus. Overall, three intraoperative positive margins were noted in the FS group (2.3%): One patient underwent radical nephrectomy and one reresection; one case was managed with observation only. CONCLUSION: Routine application of FS analysis during RAPN seems to provide a limited benefit. FS might be advisable for tumors with sinus invasion because they seem to carry a higher likelihood of positive surgical margin at final pathology determination.

Endoscopic removal of a proximal urethral stent using a holmium laser: Case report and literature review.

Urethral stents were initially developed for the management of urethral strictures and obstructive voiding disorders in select patients. Urethral stent complications are common and may require stent explantation, which is often quite challenging. We present our experience with endoscopic removal of an encrusted UroLume proximal urethral stent in a 72-year-old male using a holmium laser. The literature on various management options and outcomes for urethral stent removal is reviewed. Endoscopic removal of proximal urethral stents is feasible and safe and should be considered as the primary treatment option in patients requiring stent extraction.

High-grade prostatic intraepithelial neoplasia.

High-grade prostatic intraepithelial neoplasia (HGPIN) has been established as a precursor to prostatic adenocarcinoma. HGPIN shares many morphological, genetic, and molecular signatures with prostate cancer. Its predictive value for the development of future adenocarcinoma during the prostate-specific antigen screening era has decreased, mostly owing to the increase in prostate biopsy cores. Nevertheless, a literature review supports that large-volume HGPIN and multiple cores of involvement at the initial biopsy should prompt a repeat biopsy of the prostate within 1 year. No treatment is recommended for HGPIN to slow its progression to cancer.

Outcomes of laparoscopic and robotic radical cystectomy in the elderly patients.

OBJECTIVE: To compare the perioperative outcomes of laparoscopic/robotic radical cystectomy (LRRC) for urothelial cancer of bladder (UCB) between elderly (≥ 70 years) and younger (<70 years) patients. MATERIALS AND METHODS: A retrospective review of 146 patients who underwent LRRC between 2003 and 2010 at 2 academic institutions (Cleveland, Ohio, United States and Toulouse, France) was performed. Of these, 74 patients were classified as elderly (≥ 70 years) and 72 patients were considered younger (<70 years). Perioperative outcomes, final pathology results, overall survival (OS), and cancer specific survival (CSS) were compared between the 2 groups. RESULTS: Both groups had similar clinical stage at diagnosis, American Society of Anesthesiologists score, body mass index, and gender distribution. Ileal conduit-type diversion was favored in the older vs younger group, 84% vs 36%, respectively. Overall conversion rate to open procedures was 4% in both groups. Perioperative complication rate was not significantly different between the younger and older patients. Positive margin rate was 5% in both groups. The 5-year OS for older and younger patients was 75% and 87%, respectively (P = .03), and the 5-year CSS for the 2 groups was 51% and 54%, respectively (P = .7). CONCLUSION: Laparoscopic/robotic radical cystectomy in the elderly does not have worse perioperative complications or pathologic outcomes compared with younger patients and therefore can be offered as treatment option in select older patients.

Robotic partial nephrectomy for small renal masses in patients with pre-existing chronic kidney disease.

OBJECTIVE: To assess the outcomes of robotic partial nephrectomy in patients with pre-existing chronic kidney disease (CKD). MATERIALS AND METHODS: Patients who underwent robotic partial nephrectomy for renal tumors between 2007 and 2011 were identified from our prospectively maintained institutional database. Perioperative as well as short-term oncological and functional outcomes were assessed. A comparative analysis was performed between patients with pre-existing CKD (estimated glomerular filtration rate [eGFR] 15-60 mL/min, group 1, n = 52) and patients with eGFR >60 mL/min (group 2, n = 303). RESULTS: Group 1 patients were older (median 68 vs 57 years, P < .001), with higher American Society of Anesthesiology (ASA) score (3 vs 2, P < .001) and a higher Charlson comorbidity index (7 vs 4, P < .001). Warm ischemia time (WIT) was similar in both groups (18 vs 18 minutes, P = .52). Group 1 had a higher postoperative complication rate (40.4% vs 21.1%, P = .003). Pathologic and oncological data were similar. After a median follow-up of 3 months (interquartile: 1-10), deterioration of eGFR was lower in group 1 patients (-5% vs -12%, P = .004). No endstage renal disease was noted in either group. There was significantly less CKD upstaging in group 1 than in group 2 (11.5% vs 33.9%, P = .001). After multivariate analysis, preoperative eGFR and WIT were independent predictors of latest eGFR. Less than 15% of patients with normal baseline renal function developed CKD stage III or higher. CONCLUSION: Despite a high risk of surgical complications, robotic partial nephrectomy only marginally affects renal function in patients with pre-existing CKD.

Robotic partial nephrectomy versus laparoscopic cryoablation for the small renal mass.

BACKGROUND: Open partial nephrectomy (OPN) remains the gold standard for treatment of small renal masses (SRMs). Laparoscopic cryoablation (LCA) has provided encouraging outcomes. Robotic partial nephrectomy (RPN) represents a new promising option but is still under evaluation. OBJECTIVE: Compare the outcomes of RPN and LCA in the treatment of patients with SRMs. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively analyzed the medical charts of patients with SRMs (≤4cm) who underwent minimally invasive nephron-sparing surgery (RPN or LCA) in our institution from January 1998 to December 2010. INTERVENTION: RPN and LCA. MEASUREMENTS: Perioperative complications and functional and oncologic outcomes were analyzed. RESULTS AND LIMITATIONS: A total of 446 SRMs were identified in 436 patients (RPN, n=210; LCA, n=226). Patients undergoing RPN were younger (p<0.0001), had a lower American Society of Anesthesiologists score (p<0.001), and higher baseline preoperative estimated glomerular filtration rate (eGFR) (p<0.0001). Mean tumor size was smaller in the LCA group (2.2 vs 2.4cm; p=0.004). RPN was associated with longer operative time (180 vs 165min; p=0.01), increased estimated blood loss (200 vs 75ml; p<0.0001), longer hospital stay (72 vs 48h; p<0.0001), and higher morbidity rate (20% vs 12%, p=0.015). Mean follow-ups for RPN and LCA were 4.8 mo and 44.5 mo, respectively (p<0.0001). Local recurrence rates for RPN and LCA were 0% and 11%, respectively (p<0.0001). Mean eGFR decrease after RPN and LCA was insignificant at 1 mo, at 6 mo after surgery, and during last follow-up. Limitations include retrospective study design, length of follow-up, and selection bias. CONCLUSIONS: Both techniques remain viable treatment options in the management of SRMs. A higher incidence of perioperative complications was found in patients undergoing RPN. However, the technique was not predictive of the occurrence of postoperative complications. Early oncologic outcomes are promising for RPN, which also seems to be associated with better preservation of renal function. Long-term follow-up and well-designed prospective comparative studies are awaited to corroborate these findings.

Acceptance and durability of surveillance as a management choice in men with screen-detected, low-risk prostate cancer: improved outcomes with stringent enrollment criteria.

OBJECTIVE: To analyze the acceptance rate and durability of surveillance among contemporary men with low-risk prostate cancer managed at a large, US academic institution. METHODS: Patients with low-risk parameters on initial and repeat biopsy were offered surveillance regardless of age. Regular clinical evaluation and repeat prostate biopsy were recommended every 1-2 years, and intervention was recommended based on adverse clinical and pathologic parameters on follow-up. Acceptance rate of active surveillance, freedom from intervention, and freedom from recommended intervention were measured. RESULTS AND LIMITATIONS: Of 202 low-risk patients, 86 (43%) chose immediate treatment and 116 (57%) underwent repeat biopsy for consideration of surveillance. Intervention was recommended after initial repeat biopsy in 27 (23%) men because of higher-risk features, leaving a total of 89 men on surveillance. Over a median follow-up of 33 months, 16 men were ultimately treated and 8 were recommended to undergo treatment because of adverse clinical features on subsequent evaluations. Of the men on surveillance, the 3-year freedom from intervention and freedom from recommended intervention was 87% (95% CI, 78-93) and 93% (95% CI, 85-97), respectively. CONCLUSIONS: Acceptance of surveillance (57%) in low-risk patients in this series is substantially higher than previous reports, and approximately one-third of these patients are ultimately managed by surveillance using stringent criteria. The risk of reclassification to a more aggressive cancer over short-term follow-up in appropriately selected patients is low.

Avoiding androgen deprivation therapy in men with high-risk prostate cancer: the role of radical prostatectomy as initial treatment.

OBJECTIVE: To examine the ability of surgery as initial management in avoiding androgen deprivation therapy (ADT) in patients with high-risk localized prostate cancer. MATERIALS AND METHODS: A total of 267 men were identified from a cohort of patients treated by radical prostatectomy (RP) between January 1998 and June 2004. Patients were included if they presented with clinical stage ≥T2b and/or prostate-specific antigen (PSA) ≥15 ng/mL, and/or Gleason score ≥8. Information on biochemical recurrence, distant metastasis, cancer-specific survival, and use of ADT was obtained from a prospectively maintained database. RESULTS: The median follow-up was 6.7 years (range, 1-146 months). Biochemical recurrence (BCR), distant metastasis (DM), and prostate cancer-specific mortality (PCSM) were observed in 112 (42%), 28 (10%), and 15 (6%) patients, respectively. Salvage treatment was performed in 95 (85%) of 112 patients with BCR. Only 71 (27%) of 267 men were subjected to ADT. Overall, 8-year probabilities of freedom from BCR, DM, PCSM, and ADT were 46% (95% CI, 38-54), 87% (95% CI, 84-90), 93% (95% CI, 91-95), and 71% (95% CI, 65-77), respectively. CONCLUSIONS: RP provides excellent long-term clinical outcomes for patients with high-risk localized prostate cancer and avoids the use of ADT in approximately 70% of these patients.