Introduction:

To promote health equity within the field of urologic oncology, prostate cancer clinical trials should strive for unbiased representation.

Methods:

A systematic review of randomized clinical trials recruiting U.S. adults for prostate cancer treatment, and initiated between 2008 and 2019, was performed using four databases: Medline, Embase, Central, and the U.S. Clinical Trial registry. The Cochrane Handbook of Systematic Reviews of Interventions and PRISMA guidelines were used to identify trials. Meta-analyses were performed to obtain summary proportions and 95% confidence intervals (CI) of ethnicity and race groups. Summary proportions were compared with the corresponding Census proportions based on the 2010 U.S. Census.

Results:

The systematic review identified 54 trials (total participants, n=4009) related to prostate cancer treatment. Among them, 43% reported ethnicity (23 trials) and 72% reported race of the participants (39 trials). Proportions of Hispanics (3.35%, 95% CI 2.03-4.99), Asians (0.78%, 95% CI 0.33-1.37), American Indians (0.00%, 95% CI 0.00-0.12), and multiracial participants (0.01%, 95% CI 0.00-0.07) were lower than Census proportions (14.2%, p<.001; 5.01%, p<.001; 1.10%, p=0.002; 1.56%, p<.001). Proportions of Native Hawaiians and Pacific Islanders (NHPI) (0.91%, 95% CI 0.59-1.40) and Whites (87.5%, 95% CI 83.8-90.8) were higher than Census proportions (0.20%, p=0.011; 79.8%, p<.001). Proportion of Blacks (10.3%, 95% CI 7.11-14.0) was similar to Census proportion (12.3%, p=0.504). 

Conclusion:

These results highlight disparities in prostate cancer clinical trial recruitment. More than half of the trials did not report ethnicity. The results suggest that Hispanics, Asians, American Indians, and multiracial participants were underrepresented; NHPI and Whites were overrepresented. Overall, prostate cancer trials may not reflect the demographics of the populations sought to be served.

Funding: N/A