Axel Merseburger, MD, PhD, spoke key results of the PRESIDE trial, which examined continuous enzalutamide to treat patients with metastatic castration-resistant prostate cancer and progressive disease.
In an interview with CancerNetwork® during the 2022 Genitourinary Cancers Symposium, Axel Merseburger, MD, PhD, chairman of the Clinic of Urology at University Hospital Schleswig-Holstein in Lübeck, Germany, discussed the PRESIDE trial (NCT02288247) of enzalutamide (Xtandi) vs matched placebo plus docetaxel and prednisone for men with progressive metastatic castration-resistant prostate cancer. The study was conducted to determine a continued benefit of the androgen receptor inhibitor after disease progression.
The PRESIDE trial showed the clinical benefit of continuing enzalutamide to post-progression [treatment]. This trial was a randomized phase 3b trial in advanced metastatic castration-resistant prostate cancer, with the primary end point progression-free survival [PFS].
Besides the primary end point of PFS which was met with a 28% benefit for the combination of enzalutamide, docetaxel, and prednisone compared with the placebo, docetaxel, and prednisone [HR, 0.72; 95% CI, 0.53-0.96; P = .027]. We could demonstrate that there was a greater decrease in PSA from baseline to week 13 in the enzalutamide group at –37.12% compared with 9.11% in the placebo group.
Merseburger A, Attard G, Boysen G, et al. A randomized, double-blind, placebo (PBO)-controlled, phase 3b study of the efficacy and safety of continuing enzalutamide (ENZA) in chemotherapy-naïve, metastatic castration-resistant prostate cancer (mCRPC) patients (pts) treated with docetaxel (DOC) plus prednisolone (PDN) who have progressed on ENZA: PRESIDE. J Clin Oncol. 2022;40(suppl 6):15. doi: 10.1200/JCO.2022.40.6_suppl.015