Apalutamide is an inhibitor of the ligand-binding domain of the androgen receptor. Whether the addition of apalutamide to androgen-deprivation therapy (ADT) would prolong radiographic progression–free survival and overall survival as compared with placebo plus ADT among patients with metastatic, castration-sensitive prostate cancer has not been determined.
PURPOSE: The first interim analysis of the phase III, randomized, placebo-controlled TITAN study showed that apalutamide significantly improved overall survival (OS) and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) receiving ongoing androgen deprivation therapy (ADT). Herein, we report final efficacy and safety results after unblinding and placebo-to-apalutamide crossover. METHODS: Patients with mCSPC (N = 1,052) were randomly assigned 1:1 to receive apalutamide (240 mg QD) or placebo plus ADT. After unblinding in January 2019, placebo-treated patients were allowed to receive apalutamide. Efficacy end points were updated using the Kaplan-Meier method and Cox proportional-hazards model without formal statistical retesting and adjustment for multiplicity. Change from baseline in Functional Assessment of Cancer Therapy-Prostate total score was assessed. RESULTS: With a median follow-up of 44.0 months, 405 OS events had occurred and 208 placebo-treated patients (39.5%) had crossed over to apalutamide. The median treatment duration was 39.3 (apalutamide), 20.2 (placebo), and 15.4 months (crossover). Compared with placebo, apalutamide plus ADT significantly reduced the risk of death by 35% (median OS not reached v 52.2 months; hazard ratio, 0.65; 95% CI, 0.53 to 0.79; P < .0001) and by 48% after adjustment for crossover (hazard ratio, 0.52; 95% CI, 0.42 to 0.64; P < .0001). Apalutamide plus ADT delayed second progression-free survival and castration resistance ( P < .0001 for both). Health-related quality of life, per total Functional Assessment of Cancer Therapy-Prostate, in both groups was maintained through the study. Safety was consistent with previous reports. CONCLUSION: The final analysis of TITAN confirmed that, despite crossover, apalutamide plus ADT improved OS, delayed castration resistance, maintained health-related quality of life, and had a consistent safety profile in a broad population of patients with mCSPC.
Objective: To compare the early peri‐operative, oncological and continence outcomes of R etzius‐sparing robot‐assisted laparoscopic radical prostatectomy ( RALP ) with those of conventional RALP . Materials and Methods: Data from 50 patients who underwent R etzius‐sparing RALP and who had at least 6 months of follow‐up were prospectively collected and compared with a database of patients who underwent conventional RALP . Propensity‐score matching was performed using seven preoperative variables, and postoperative variables were compared between the groups. Results: A total of 581 patients who had undergone RALP were evaluated in the present study. Although preoperative characteristics were different before propensity‐score matching, these differences were resolved after matching. There were no significant differences in mean length of hospital stay, estimated blood loss, intra‐ and postoperative complication rates, pathological stage of disease, G leason scores, tumour volumes and positive surgical margins between the conventional RALP and Retzius‐sparing RALP groups. Console time was shorter for R etzius‐sparing RALP . Recovery of early continence (defined as 0 pads used) at 4 weeks after RALP was significantly better in the Retzius‐sparing RALP group than in the conventional RALP group. Conclusions: The present results suggest that R etzius‐sparing RALP , although technically more demanding, was as feasible and effective as conventional RALP , and also led to a shorter operating time and faster recovery of early continence. Retzius‐sparing RALP was also reproducible and achievable in all cases.
The objective of this review was to describe the epidemiology and risk factors of prostate cancer (PCa) in Asian populations. English language publications published over the last 10 years covering studies on the incidence, mortality, and risk factors of PCa in Asia were reviewed. The incidence of PCa in Asia is rising but is still significantly lower than that in Western countries. Studies in Asia indicated that the consumption of red meat, fat, dairy, and eggs was associated with a higher risk for PCa. Age and family history were also found to be risk factors. The emergence of genetic data indicates that different genetic backgrounds between Asian and Western populations play a role in the observed differences in PCa incidence. The lower incidence of PCa in Asian men than in Western men may in part be due to a lack of systematic prostate-specific antigen screening, but environmental and genetic factors also play a role.