Open AccessPhase II Trial of Abiraterone Acetate Plus Prednisone in Black Men With Metastatic Prostate Cancer
Author(s) -
Tsao CheKai,
Sfakianos John,
Liaw Bobby,
GimpelTetra Kiev,
Kemeny Margaret,
Bulone Linda,
Shahin Mohammad,
Oh William Kyu,
Galsky Matthew David
Publication year - 2016
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2016-0026
Subject(s) - abiraterone acetate , medicine , prostate cancer , prednisone , oncology , clinical trial , cancer , androgen deprivation therapy
Lessons LearnedThe safety and activity findings of abiraterone acetate plus prednisone treatment in black men with mCRPC were similar to results from previously conducted studies with largely white populations. Poor trial accrual continues to be a challenge in black men with mCRPC and further efforts are needed to address such underrepresentation.Background. Self‐identified black men have higher incidence and mortality from prostate cancer in the United States compared with white men but are dramatically underrepresented in clinical trials exploring novel therapies for metastatic castration‐resistant prostate cancer (mCRPC). Methods. Black men with mCRPC were treated with abiraterone acetate (AA), 1,000 mg daily, and prednisone (P), 5 mg twice daily. The primary objective was to determine antitumor activity (defined by a ≥30% decline in prostate‐specific antigen [PSA] level) and to correlate germline polymorphisms in androgen metabolism genes with antitumor activity. Secondary objectives included determining safety, post‐treatment changes in measurable disease, and time to disease progression. Results. From April 2013 to March 2016, a total of 11 black men were enrolled and received AA plus P (AA+P); 7 of 10 evaluable patients were docetaxel naive. Post‐treatment declines in PSA level of ≥30% were achieved in 90% of patients. The side effect profile was consistent with prior clinical trials exploring AA+P in mCRPC. Due to poor accrual, the study was closed prematurely with insufficient sample size for the planned pharmacogenetic analyses. Conclusion. In this small prospective study terminated for poor accrual, the safety and activity of AA+P in black men with mCRPC was similar to that reported in prior studies exploring AA in largely white populations. Further efforts are needed to address underrepresentation of black men in mCRPC trials.