Enzalutamide Reduces Risk of Metastasis in Castration-Resistant Prostate Cancer
Researchers randomly assigned 1401 men with M0 CRPC undergoing ADT to receive enzalutamide 160 mg or placebo.
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Enzalutamide plus androgen deprivation therapy (ADT) greatly reduces the risk of metastasis in men with non-metastatic castration-resistant prostate cancer (M0 CRPC) compared with ADT alone, according to data being presented at the 2018 Gastrointestinal Cancers Symposium in San Francisco, California.1
Previous studies demonstrated that men with metastatic CRPC treated with enzalutamide had improved overall survival (OS) and radiographic progression-free survival (PFS); researchers investigated the effect of enzalutamide in M0 CRPC.
For the phase 3 PROSPER study (ClinicalTrials.gov Identifier: NCT02003924), researchers randomly assigned 1401 men with M0 CRPC undergoing ADT to receive enzalutamide 160 mg or placebo.
The median duration of treatment was 18.4 months and 11.1 months for the enzalutamide and placebo arms, respectively. Patients in the enzalutamide arm had a significantly longer median metastasis-free survival of 36.6 months compared with 14.7 months among patients in the placebo arm (P < .0001), as well as improvements in time to PSA progression (37.2 months vs 3.9 months; P < .0001).
Patients in the enzalutamide arm had a favorable trend towards improved OS.
Adverse events (AEs) occurred at a higher rate among patients treated in enzalutamide, with an any-grade AE rate of 87% compared with 77% in the placebo arm. Ten percent vs 8% of patients in the enzalutamide vs placebo arm discontinued therapy because of an AE, respectively.
The authors concluded that “in men with M0 CRPC and rapidly rising PSA, [enzalutamide] treatment resulted in a clinically meaningful and statistically significant 71% reduction in the risk of developing M1 CRPC.”
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- Hussain M, Fizazi K, Saad F, et al. PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC). Oral presentation at: 2018 Genitourinary Cancers Symposium; February 8-10, 2018; San Francisco, CA.