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Atish D. Choudhury, MD, PhD, discusses the design of key clinical trials in nonmetastatic castration-resistant prostate cancer.
Atish D. Choudhury, MD, PhD, co-director of the Prostate Cancer Center and senior physician at Dana-Farber Cancer Institute, as well as an instructor in medicine at Harvard Medical School, discusses the design of key clinical trials in nonmetastatic castration-resistant prostate cancer (CRPC).
Darolutamide (Nubeqa), enzalutamide (Xtandi), and apalutamide (Erleada) have demonstrated similar overall survival benefits for men with nonmetastatic CRPC who are receiving androgen deprivation therapy (ADT).
The phase 3 ARAMIS, PROSPER, and SPARTAN trials, which evaluated these agents, had similar trial designs and eligibility criteria, Choudhury explains. For example, all patients had nonmetastatic CRPC and a castrate level of testosterone.
The PROSPER and ARAMIS trials enrolled patients with pelvic lymph nodes up to 1.5 cm in size, Choudhury says. In the SPARTAN trial, patients with lymph nodes up to 2 cm in size were eligible for enrollment.
All 3 studies were placebo controlled, and patients were randomized 2:1 to the investigational antiandrogen agent or placebo, plus ADT. Additionally, metastasis-free survival served as the primary end point in the 3 studies, concludes Choudhury.