EMBARK demonstrated prolonged metastasis-free survival with enzalutamide ± leuprolide versus leuprolide alone for patients with high-risk biochemical recurrence of prostate cancer, with health-related quality of life (HRQoL) maintained. To evaluate treatment effects on sexual activity (SA), item-level analyses of SA-related HRQoL were performed. HRQoL was assessed (baseline, every 12 wk) until metastasis or death. Time to confirmed clinically meaningful deterioration (TTCD; confirmed at next visit) and longitudinal changes in HRQoL were examined using Cox regression and mixed-model repeated measures analyses, respectively. In comparison to leuprolide alone, enzalutamide monotherapy delayed TTCD in interest in sex (8.5 vs 5.6 mo; hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.57-0.87; p < 0.001), extent of SA (5.7 vs 3.0 mo; HR 0.69, 95% CI 0.54-0.90; p = 0.004), satisfaction with sex life (11.1 vs 5.4 mo; HR 0.61, 95% CI 0.45-0.84; p = 0.001), and erectile function (5.5 vs 2.9 mo; HR 0.67, 95% CI 0.50-0.88; p = 0.003). TTCD in SA-related HRQoL was similar with enzalutamide + leuprolide and leuprolide alone, except TTCD in erectile function was shorter by a statistically significant median of 0.1 mo (3 d), which is not clinically meaningful. Longitudinally, no clinically meaningful changes for any SA-related item were observed from baseline to week 205 in any group. SA-related HRQoL preservation seems to be better with enzalutamide monotherapy than with leuprolide alone.
European urology. 2025 Feb 26 [Epub ahead of print]
Stephen J Freedland, John P Mulhall, Martin Gleave, Ugo De Giorgi, Fred Saad, Antti Rannikko, Jasmina I Ivanova, Anchen F Nasr, Arlene L Reisman, Arijit Ganguli, Pavol Kral, James Turnbull, Neal Shore
Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Durham VA Medical Center, Durham, NC, USA., Memorial Sloan-Kettering Cancer Center, New York, NY, USA., Vancouver Prostate Center, Vancouver, Canada., IRCCS Istituto Romagnolo per lo Studio dei Tumori, Meldola, Italy., Centre Hospitalier de l'Universite de Montreal, University of Montreal, Montreal, Canada., Department of Urology and Research Program in Systems Oncology, University of Helsinki, and Helsinki University Hospital, Helsinki, Finland., Pfizer Inc., New York, NY, USA., Medical Affairs, Astellas Pharma Inc., Northbrook, IL, USA., IQVIA Inc., Bratislava, Slovakia., IQVIA Inc., New York, NY, USA., Carolina Urologic Research Center, Myrtle Beach, SC, USA. Electronic address: .