Kim Chi, MD, discusses the design of the phase 3 AMPLITUDE trial in metastatic castration-sensitive prostate cancer.
Kim Chi, MD, senior research scientist, Vancouver Prostate Centre, chief medical officer, vice president, medical oncologist, BC Cancer, professor, Department of Medicine, The University of British Columbia, discusses the design of the phase 3 AMPLITUDE trial (NCT04497844) in metastatic castration-sensitive prostate cancer (mCSPC).
The randomized AMPLITUDE trial of niraparib (Zejula) in combination with abiraterone acetate (Zytiga) is examining the utility of bringing effective treatments in metastatic castration-resistantprostate cancer earlier to cancers that are castration sensitive, Chi says. Patients with an alteration in a specified list of homologous recombination repair–associated genes, including BRCA2, are eligible for enrollment on the study, Chi adds. Patients are randomized to niraparib in combination with abiraterone and prednisone vs abiraterone and prednisone alone. Additionally, all patients receive standard androgen-deprivation therapy.
The primary end point of the study is radiographic progression-free survival (PFS), and an important secondary end point is overall survival, Chi continues. Additional end points include symptomatic PFS, time to subsequent therapy, and adverse effects. Moreover, the international, multicenter trial is currently enrolling patients, Chi concludes.