Dr. Agarwal on the Design of the AMPLITUDE Trial in mCSPC

Neeraj Agarwal, MD, professor of medicine, Presidential Endowed Chair of Cancer Research, director of Genitourinary Oncology Program and the Center of Investigational Therapeutics, Huntsman Cancer Institute, University of Utah, discusses the design of the ongoing phase 3 AMPLITUDE trial (NCT04497844) in metastatic castration-sensitive prostate cancer (mCSPC).

The AMPLITUDE study is a randomized study enrolling patients with mCSPC who harbor deleterious germline or somatic homologous recombination repair (HRR) gene mutations, Agarwal says. Patients receiving androgen-deprivation therapy are randomized to niraparib (Zejula) plus abiraterone acetate (Zytiga) and prednisone vs abiraterone and prednisone alone. Niraparib is an established PARP inhibitor in prostate cancer, having demonstrated efficacy and tolerability in earlier ​phase 1 and 2 trials, Agarwal adds.

Overall, AMPLITUDE is a large trial, with a patient accrual goal of 788 individuals. The primary end point of the study is radiographic progression free survival (PFS), Agarwal continues. Secondary endpoints include overall survival, symptomatic PFS, time to subsequent therapy, and safety and tolerability, Agarwal concludes.