title: Phase II Trial of Abiraterone Acetate Plus Prednisone in Black Men With Metastatic Prostate Cancer.
abstract: The 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA matthew.galsky@mssm.edu.
authors.forename: Che-Kai
authors.initials: CK
authors.lastname: Tsao
authors.affiliation: Department of Urology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
authors.forename: John
authors.initials: J
authors.lastname: Sfakianos
authors.affiliation: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
authors.forename: Bobby
authors.initials: B
authors.lastname: Liaw
authors.affiliation: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
authors.forename: Kiev
authors.initials: K
authors.lastname: Gimpel-Tetra
authors.affiliation: Queens Hospital Center, Jamaica, New York, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Kemeny
authors.affiliation: Queens Hospital Center, Jamaica, New York, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Bulone
authors.affiliation: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Shahin
authors.affiliation: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
authors.forename: William Kyu
authors.initials: WK
authors.lastname: Oh
authors.affiliation: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
authors.forename: Matthew David
authors.initials: MD
authors.lastname: Galsky
mesh_terms: D000069501:Abiraterone Acetate / Q000008:administration & dosage / Q000009:adverse effects; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D044383:Black People; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology
chemical_list: D000069501:Abiraterone Acetate; D011241:Prednisone