Multicentre, prospective study on local treatment of metastatic prostate cancer (LoMP study).

OBJECTIVES: To investigate the role of cytoreductive radical prostatectomy in addition to standard of care for patients with newly diagnosed metastatic prostate cancer. MATERIALS AND METHODS: This multicentre, prospective study included asymptomatic patients from 2014 to 2018 (NCT02138721). Cytoreductive radical prostatectomy was offered to all fit patients with resectable tumours, resulting in 40 patients. Standard of care was administered to 40 patients who were ineligible or unwilling to undergo surgery. The primary endpoint was castration resistant cancer-free survival at the time point of ≥50% events. The secondary endpoint was local event-free survival. Kaplan-Meier and Cox regression analyses with propensity-score analysis were applied. RESULTS: After a median (quartiles) follow-up of 35 (24-47) months, 42 patients became castration-resistant or died. The median castration resistant cancer-free survival was 53 (95% confidence interval [CI] 14-92) vs 21 (95% CI 15-27) months for cytoreductive radical prostatectomy compared to standard of care (P = 0.017). The 3-year estimates for local event-free survival were 83% (95% CI 71-95) vs 59% (95% CI 51-67) for cytoreductive radical prostatectomy compared to standard of care (P = 0.012). However, treatment group showed no significance in the multivariable models for castration resistant cancer-free survival (P = 0.5) or local event-free survival (P = 0.3), adjusted for propensity-score analysis. Complications were similar to the non-metastatic setting. Patients undergoing surgery were younger, with lower baseline prostate-specific antigen levels, alkaline phosphatase levels and metastatic burden. CONCLUSION: The present LoMP study was unable to show a difference between the two inclusion groups regarding castration resistant cancer-free survival for asymptomatic patients with newly diagnosed metastatic prostate cancer. These results validate previous evidence that, in well-selected and informed patients, cytoreductive radical prostatectomy is feasible and safe, with corresponding continence rates compared to the non-metastatic, high-risk setting. Whether cytoreductive radical prostatectomy could be a valuable option to achieve good local palliation needs to be further researched. Overall, the role of cytoreductive radical prostatectomy needs to be further explored in randomized studies to correct for potential bias.

Cytoreductive Prostatectomy for Metastatic Prostate Cancer: First Lessons Learned From the Multicentric Prospective Local Treatment of Metastatic Prostate Cancer (LoMP) Trial.

OBJECTIVE: To prospectively evaluate patients with newly diagnosed metastatic prostate cancer in the context of the LoMP trial (which investigates the role of cytoreductive radical prostatectomy [cRP] in addition to standard of care [SoC]) and to provide a preliminary analysis of patient's characteristics, safety of cRP, and early local symptoms. PATIENTS AND METHODS: cRP was performed in asymptomatic patients with a resectable tumor and who were fit to undergo surgery (group A, n = 17). Only SoC was administered to patients with metastatic prostate cancer ineligible or unwilling to undergo cRP (group B, n = 29). At 3 months, surgical complications related to cRP and local symptoms for both groups were evaluated. RESULTS: Median operation time, blood loss, and hospital stay for cRP were 215 minutes (150-290), 250 mL (100-900), and 4 days (2-7), respectively. Respectively 5 (29.4%) and 2 (11.8%) patients suffered grades 1 and 2 complications within 3 months postoperatively. When compared with Group B, patients in group A were younger (64 vs 72 years, P = .005), had lower initial prostate-specific antigen (15.9 vs 156 µg/L, P = .002), and less high-volume metastatic disease (5.9% vs 69%, P <.001). At 3 months, 5 (29.4%) patients in group A reported stress urinary incontinence without any further local symptoms. In group B, respectively 2 (6.8%), 11 (37.9%), and 2 (6.8%) patients suffered urge incontinence, obstructive voiding needing medical intervention, and ureteric obstruction. CONCLUSION: In a group of well-selected patients, cRP is safe. These patients have more favorable characteristics compared with patients treated with only SoC. If only SoC can be offered, patients are at risk to suffer from local symptoms.

A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up.

INTRODUCTION AND HYPOTHESIS: Midurethral sling procedures have become the principal surgical treatment for women with stress urinary incontinence (SUI). The 1-year results of this international trial comparing the efficacy and morbidity of a single-incision midurethral sling (SIMS; MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) showed that MiniArc is non-inferior regarding subjective cure and superior with regard to postoperative pain and recovery. The objective was to compare subjective and objective cure, morbidity and surgery-related discomfort following SIMS and transobturator SMUS up to a 24-month follow-up. METHODS: We carried out a non-blinded, randomised, controlled trial. Women with symptomatic SUI were eligible. Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I), at 12, 24 and 36 months. Secondary outcomes were objective cure based on the cough stress test, disease-specific quality of life questionnaires, surgical parameters and physical performance during recovery. Analysis was by intent to treat. Differences between the two groups regarding dichotomous variables were Chi-squared tested and presented as relative risks (RR) with corresponding 95 % confidence intervals. RESULTS: We randomised 97 women to MiniArc and 96 to Monarc. At the 24-month follow-up, subjective cure was 84 % following MiniArc and 89 % following Monarc (RR -5; 95% CI -0.17 to 0.06). Objective cure was 93 % following MiniArc and 94 % following Monarc (RR -1; 95% CI -0.10 to 0.07). Both procedures have low complication rates. CONCLUSIONS: At the 2-year follow-up, the non-prespecified analysis of this randomised trial showed that the MiniArc, a single-incision sling, had similar subjective and similar objective cure rates, although non-inferiority to Monarc for subjective cure could not be demonstrated.

A randomized comparison of a single-incision midurethral sling and a transobturator midurethral sling in women with stress urinary incontinence: results of 12-mo follow-up.

BACKGROUND: Midurethral sling procedures have become the prime surgical treatment for women with stress urinary incontinence (SUI). Single-incision mini-slings (SIMS) potentially offer similar efficacy with reduced morbidity. This international multicenter trial compared the efficacy and morbidity of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS) (Monarc). OBJECTIVE: To compare subjective and objective cure, morbidity, and surgery-related discomfort following SIMS and transobturator SMUS. DESIGN, SETTING, AND PARTICIPANTS: Prospective randomized controlled trial with an initial follow-up period of 12 mo. Women with symptomatic SUI were eligible. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I). Coprimary outcome was the mean visual analog scale (VAS) pain score (0-100) during 3 d after surgery. Secondary outcomes were objective cure based on the cough stress test (CST), disease-specific quality of life determined by the Urogenital Distress Inventory (UDI-6) score, surgical parameters, and physical performance during recovery. Analysis was by intent to treat. Differences between the MiniArc and Monarc groups on dichotomous variables were chi-square tested and presented as relative risks (RR) with corresponding 95% confidence intervals. We hypothesized that MiniArc was noninferior to Monarc concerning subjective cure and superior concerning postoperative pain. RESULTS AND LIMITATIONS: We randomized 97 women to MiniArc and 96 to Monarc. At 12-mo follow-up, subjective cure was 83% following MiniArc and 86% following Monarc (p=0.46). Objective cure was 89% following MiniArc and 91% following Monarc (p=0.65). The mean pain VAS score during the first three postoperative days was 9 following MiniArc and 22 following Monarc (Mann-Whitney U test, p<0.01). CONCLUSIONS: At 1-yr follow-up, MiniArc was noninferior to Monarc with respect to subjective and objective cure and superior with respect to postoperative pain. PATIENT SUMMARY: This 1-yr randomized clinical trial showed that MiniArc, a single-incision midurethral sling, is noninferior to Monarc, a transobturator sling, with respect to cure and superior with respect to pain and recovery.