Under-Representation of Black and Hispanic Men in Metastatic Castration-Resistant Prostate Cancer Trials (2005-2021): A Call to Action.

Abstract

Black men face the highest incidence and mortality rates of prostate cancer globally, including a disproportionate burden of metastatic castration-resistant prostate cancer (mCRPC). Despite this, clinical trials often fail to adequately represent the populations most affected. This study evaluates representation trends in mCRPC trials over a 17-year period. We analyzed 33 phase III and IV mCRPC trials (2005-2021) registered on ClinicalTrials.gov. Data on race, ethnicity, and trial geography were extracted. Representation trends were assessed across time intervals and funding sources. A random-effects model was used to analyze pooled participant demographics. Of 33 trials (n = 28,746), 73% reported race and 42% reported ethnicity. Among trials with available data, 79.2% of participants were White, 10.8% were Asian, and only 3.8% were Black or African American. Hispanic participation was 6.7%. Notably, Black participation declined from 13.7% to 3% over the study period. Trial sites were predominantly located in North America and Europe, with no inclusion from Africa or the Caribbean. Racial and ethnic under-representation in mCRPC trials has remained profound and, in some cases, worsened, despite increasing awareness. These findings underscore a critical need for structural reforms in trial design, funding, and regulatory oversight to ensure equitable access and generalizability of prostate cancer therapies.