Abstract: PD09-05
Sources of Funding: Departmental, NIH (U54MD008620)

Introduction

Black men experience the highest prostate cancer burden in the United States and globally. One of the factors that may contribute to the slow progress in eliminating prostate cancer disparities among Black men is their underrepresentation in randomized controlled trials (RCTs) of new treatment modalities. We conducted this study to assess the current status of Black men's participation in RCTs for prostate cancer.

Methods

We performed a protocol-driven systematic review for all published prostate cancer RCTs over a 25-year time period (1991-2015) searching PUBMED. We only included RCTs of patients with an established diagnosis of prostate cancer and excluded studies of screening and diagnosis. For studies that resulted in multiple publications, only the initial study was included. We excluded secondary and subgroup analyses.

Results

We found 584 unique trials that met the inclusion criteria, which we analyzed by type of intervention, sample size, disease stage, number of sites, origin, type of funding, publication year, the year enrollment began, and whether the study reported the inclusion of Black men. The median sample size of all trials was 125.5 (IQR = 60-286.5) and the median number of sites was 5 (IQR = 1-22). One hundred and eleven of the 584 (19.0%) trials worldwide and 81 of 189 (42.9%) of trials conducted exclusively within the US reported the enrollment of Black men. Of those trials that reported the inclusion of Black men, the median percentage of the study population was 10.55% overall (IQR = 6.6%-19.8%) and 12.27% (IQR = 7.0%-21.2%) for studies based exclusively in the United States. Among the 111 trials that reported the racial composition of participants, the median number of Black patients was 20 (IQR = 8-37.5). In studies conducted exclusively within the US, the median number of black patients was 17 (IQR = 8-31).

Conclusions

Less than 1 in 5 studies globally and half of studies from the US reported the participation of Black men. We found no study that enrolled Black men exclusively or that prospectively stratified analysis based on race. There is a critical need for greater involvement and better reporting of Black men's participation in prostate cancer trials.

Funding

Departmental, NIH (U54MD008620)