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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. [ABSTRACT FROM AUTHOR]

Objective: To develop a novel tool to increase the number of patients with prostate cancer eligible for active surveillance (AS) without increasing the risk of unfavourable pathological features (i.e., misclassification) at radical prostatectomy (RP). Patients and Methods: Overall, 16 049 patients with low‐ or intermediate‐risk prostate cancer treated with RP were identified. Misclassification was defined as non‐organ confined or grade group ≥3 disease at RP. The coefficients of a logistic regression model predicting misclassification were used to develop a risk score. We then performed a systematic analysis of different thresholds to discriminate between patients with or without unfavourable disease and we compared it to available AS criteria. Results: Overall, 5289 (33.0%) patients had unfavourable disease. At multivariable analyses, PSA level, clinical stage, biopsy grade group, the number of positive cores, and PSA density were associated with the risk of unfavourable disease (all P < 0.001). The Prostate Cancer Research International: Active Surveillance (PRIAS) criteria were associated with a lower risk of misclassification (13%) compared to other criteria. Overall, 3303 (20.6%) patients were eligible according to the PRIAS protocol. The adoption of an 18% threshold according to the risk score increased the proportion of eligible patients from 20.6% to 29.4% without increasing the risk of misclassification as compared to the PRIAS criteria. Conclusions: The use of a novel risk score for AS selection would result in an absolute increase of 10% in the number of patients eligible for this approach without increasing the risk of misclassification. [ABSTRACT FROM AUTHOR]

Objective To conduct a central pathology review within a randomized clinical trial on salvage radiation therapy ( RT) in the presence of biochemical recurrence after prostatectomy to assess whether this results in changes in histopathological prognostic factors, such as Gleason score. Patients and Methods A total of 350 patients were randomized and specimens from 279 patients (80%) were centrally reviewed by a dedicated genitourinary pathologist. Gleason score, tumour classification and resection margin status were reassessed and compared with the results of local pathology review. Agreement was assessed using contingency tables and Cohen's kappa coefficient. The association between other histopathological features (e.g. largest diameter of carcinoma) and rapid biochemical progression (up to 6 months after salvage RT) was also investigated. Results There was good concordance between central and local pathology review for seminal vesicle invasion ( pT3b: 91%; κ = 0.95 [95% confidence interval { CI} 0.89, 1.00]), extraprostatic extension ( pT3a/b: 94%; κ = 0.82 [95% CI 0.75, 0.89]) and positive surgical margin ( PSM) status (87%; κ = 0.7 [95% CI 0.62, 0.79]). The rate of agreement was lower for Gleason score (78%; κ = 0.61 [95% CI 0.52, 0.70]). The median (range) largest diameter of carcinoma was 16 (3-38) mm. A total of 49 patients (18%) experienced rapid biochemical progression after salvage RT. Largest diameter of carcinoma (odds ratio [ OR] 2.04 [95% CI 1.30, 3.20]; P = 0.002), resection margin status ( OR 0.36 [95% CI 0.18, 0.72]; P = 0.004) and Gleason score ( OR 1.55 [95% CI 1.00, 2.42]; P = 0.05) remained associated with rapid progression after salvage RT after backward selection. Conclusion The results of the central pathology analyses showed concordance between central and local pathology review with regard to seminal vesicle invasion, extraprostatic extension and PSM status, but a lower rate of agreement for Gleason score. Largest diameter of carcinoma was found to be a potential prognostic factor for rapid biochemical progression after salvage RT. [ABSTRACT FROM AUTHOR]