ORLANDO, FL, USA (UroToday.com) - Despite an almost 2-fold greater incidence of prostate cancer in African American (AA) men vs Caucasian populations, AA men are underrepresented in randomized clinical trials (RCT), and in particular three phase 3 RCTs evaluating sipuleucel-T where the enrollment was 5.8% (n = 43). While no conclusions were drawn, median overall survival (OS) suggested AAs benefit from sipuleucel-T.
PROCEED is an ongoing phase 4 registry that expanded efforts to increase AA enrollment to better characterize the safety, product parameters, and overall survival in this population. The abstract presented evaluates whether PROCEED was successful in recruiting AA men.
PROCEED enrolled 1 973 men within 6 months of registration. Efforts such as selecting racially diverse sites and highlighting AA enrollment in PROCEED communications and investigator meetings were used to boost AA enrollment. Baseline Gleason score, Eastern Cooperative Oncology Group performance status (ECOG), prostate-specific antigen (PSA), and alkaline phosphatase (ALP) were compared between RCTs and PROCEED. Safety and survival analyses are ongoing.
PROCEED AA enrollment was 11.6% vs 7.1% US RCT nonwhite enrollment rate and approaches the US AA population of 13.7%. Baseline AA patient characteristics were: lower median PSA and ALP levels in PROCEED vs RCTs, higher ECOG > 0 in PROCEED vs RCTs, and higher Gleason score ≥ 8 in PROCEED vs RCTs. The lower baseline PSA of AAs in PROCEED is similar to the PSA observed in the entire PROCEED population.
In conclusion, efforts to boost AA enrollment in PROCEED to a proportion comparable to the US AA population succeeded. Key activities enhanced AA enrollment, which include utilizing racially diverse sites, employing study materials designed to appeal to broad audiences, and engaging research staff in recruitment efforts. Safety, product parameters, and OS are not reported and will be reported after longer follow-up.
Presented by Ronald F. Tutrone, Chiledum Ahaghotu, Andrew J. Armstrong, Celestia S. Higano, Matthew R. Cooperberg, Laurence H. Belkoff, Carl A. Olsson, Sanjay Goel, Robert Claude Tyler, Jennifer Susan LIll, Todd E. Gray, Candice McCoy, and A. Oliver Sartor at the 2015 Genitourinary Cancers Symposium - "Integrating Biology Into Patient-Centric Care" - February 26 - 28, 2015 - Rosen Shingle Creek - Orlando, Florida USA
Chesapeake Urologic Research Associates, Baltimore, MD; Howard University Hospital, Washington, DC; Duke University, Durham, NC; Seattle Cancer Care Alliance, University of Washington, Seattle, WA; University of California, San Francisco, San Francisco, CA; Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA; Integrated Medical Professionals, PLLC, Columbia University Medical Center, North Hills, NY; Montefiore Einstein Cancer Center, Bronx, NY; Dendreon Corporation, Seattle, WA; Tulane University School of Medicine, New Orleans, LA
Reported by Mohammed Haseebuddin, MD, medical writer for UroToday.com