Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

Summary

This randomized phase II trial studies abiraterone acetate and prednisone together with veliparib to see how well it works compared to abiraterone acetate and prednisone alone in treating patients with castration-resistant prostate cancer that has spread from the primary site to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abiraterone acetate together with prednisone and veliparib may work better than abiraterone acetate and prednisone alone in treating patients with castration-resistant prostate cancer.

Timeline

Start

2012-03-30

Primary completion

2019-10-23

Completion

2020-04-23

Outcome

Missed primary endpoint

paper There were no differences in PSA RR (63.9% v 72.4%; P = .27) PMID 29261439 ↗

registry analysis (superiority test); Arm I (Abiraterone Acetate and Prednisone) vs Arm II (Abiraterone Acetate, Prednisone, and Veliparib); p = 0.27; Chi-squared NCT01576172 ↗

Publications

• Hussain M, Daignault-Newton S, Twardowski PW, Albany C, Stein MN, Kunju LP, Siddiqui J, Wu YM, Robinson D, Lonigro RJ, Cao X, Tomlins SA, Mehra R, Cooney KA, Montgomery B, Antonarakis ES, Shevrin DH, Corn PG, Whang YE, Smith DC, Caram MV, Knudsen KE, Stadler WM, Feng FY, Chinnaiyan AM. Targeting Androgen Receptor and DNA Repair in Metastatic Castration-Resistant Prostate Cancer: Results From NCI 9012. J Clin Oncol. 2018 Apr 1;36(10):991-999. doi: 10.1200/JCO.2017.75.7310. Epub 2017 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abiraterone acetate	Small molecule	—	Oral
Subject	Veliparib	Small molecule	—	Oral
Background	Prednisone	Other / unclassified	—	Oral

Indications