An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Summary

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.

Timeline

Start

2016-08-31

Primary completion

2021-01-26

Completion

2023-08-16

Publications

• Smith MR, Sandhu S, George DJ, Chi KN, Saad F, Thiery-Vuillemin A, Stahl O, Olmos D, Danila DC, Gafanov R, Castro E, Moon H, Joshua AM, Mason GE, Espina BM, Liu Y, Lopez-Gitlitz A, Francis P, Bevans KB, Fizazi K. Health-related quality of life in GALAHAD: A multicenter, open-label, phase 2 study of niraparib for patients with metastatic castration-resistant prostate cancer and DNA-repair gene defects. J Manag Care Spec Pharm. 2023 Jul;29(7):758-768. doi: 10.18553/jmcp.2023.29.7.758.
• Smith MR, Scher HI, Sandhu S, Efstathiou E, Lara PN Jr, Yu EY, George DJ, Chi KN, Saad F, Stahl O, Olmos D, Danila DC, Mason GE, Espina BM, Zhao X, Urtishak KA, Francis P, Lopez-Gitlitz A, Fizazi K; GALAHAD investigators. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):362-373. doi: 10.1016/S1470-2045(21)00757-9. Epub 2022 Feb 4.

Drugs

Indications