Racial disparities in metastatic castration-resistant prostate cancer clinical trials between 2005 and 2021.

Abstract

e17061 Background: Despite significant racial and ethnic disparities in prostate cancer incidence and mortality in the United States and worldwide, clinical trials frequently fail to represent the disease incidence across different racial and ethnic groups. Incorporating diverse racial and ethnic groups in clinical trials enhances our understanding of treatment responses, benefits, and side effects, which is essential for informed clinical decisions. This study aims to review the reporting of race and ethnicity data and the representation of race and ethnicity in metastatic castration-resistant prostate cancer (mCRPC) clinical trials. Methods: 33 completed phase III and IV mCRPC clinical trials (2005-2021) from ClinicalTrials.gov were analyzed. Demographic data on race, ethnicity, and trial locations were extracted and analyzed using Microsoft Excel. Two independent reviewers extracted data from each study to conduct a random-effects analysis. The primary outcome was identifying the prevalence of studies lacking racial/ethnic data. The secondary outcomes are temporal changes in the racial/ethnic diversity of participants in 5 year periods and geographic representation of countries. Results: Of the 33 trials analyzed, 72.7% had available race data, and 58.3% of these reported ethnicity. Trials with available race data revealed 79.2% White, 10.8% Asian, 3.8% Black, and 5.7% combined other participants. 6.7% of the participants were Hispanic. Temporal change analyzed in 5-year intervals demonstrated that the percentage of White participants declined from 81.1% to 71.8%. Importantly, there was a decrease in the representation of Black men from 13.7% to 3%. The majority of countries participating in prostate cancer clinical trials are located in North America and Europe. Only 2 African countries recruited participants for the clinical trials analyzed in this study. Conclusions: Globally, 27.3% of clinical trials for mCRPC did not report racial data, which raises concerns about their generalizability. Despite growing awareness of the racial disparities in prostate cancer outcomes, white participants are over 70% of the total participant population during each 5 year time period analyzed, and Black and Hispanic men are significantly underrepresented. These findings underscore racial/ethnic disparities in mCRPC clinical trials, warranting further investigation into recruitment barriers for equitable participation. Trials (n= 24) Participants (n=21779) Race groups represented, n (%)  White 24 (100) 17258 (79.2)  Black or African American 24 (100) 833 (3.8)  Asian 22 (91.6) 2368 (10.8)  American Indian or Alaskan Native 17 (70.8) 125 (0.5)  Native Hawaiian or Pacific Islander 18 (75) 28 (0.1)  More than one race 14 (58.3) 72 (0.3)  Other or no answer 23 (95.8) 1024 (4.7) Ethnicity categories represented, n (%)  Hispanic or Latino 14 (58.3) 1461 (6.7)  Not Hispanic or Latino 14 (58.3) 11537 (52.9)