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Updated: Jan 10, 2026

A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
Under-Representation of Black and Hispanic Men in Metastatic Castration-Resistant Prostate Cancer Trials (2005-2021):
Canan D Dirican1, Sagar Patel2, Anas Al Mardini1
1NYMC Internal Medicine Residency Program at Saint Mary's and Saint Clare's, Denville, NJ.
Purpose:
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.
Materials And Methods:
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.
Results:
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.
Conclusion:
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.
Insights
Black men face high prostate cancer burdens but are underrepresented in clinical trials. Their participation in metastatic castration-resistant prostate cancer trials has declined, highlighting a need for improved trial diversity.
Area of Science:
- Oncology
- Clinical Trials
- Health Disparities
Background:
- Black men experience the highest prostate cancer incidence and mortality rates globally.
- Metastatic castration-resistant prostate cancer (mCRPC) disproportionately affects this population.
- Clinical trials often lack adequate representation of key demographic groups.
Purpose of the Study:
- To evaluate representation trends of racial and ethnic groups in mCRPC clinical trials over a 17-year period.
- To assess changes in participant demographics in mCRPC trials from 2005 to 2021.
Main Methods:
- Analysis of 33 phase III and IV mCRPC trials registered on ClinicalTrials.gov (2005-2021).
- Extraction of data on participant race, ethnicity, and trial geography.
- Assessment of representation trends over time and by funding source, using a random-effects model for pooled demographics.
Main Results:
- Only 73% of trials reported race and 42% reported ethnicity.
- White participants constituted 79.2%, Asian 10.8%, and Black or African American participants only 3.8%.
- Black participation decreased from 13.7% to 3% during the study period; trials were geographically limited to North America and Europe.
Conclusions:
- Profound racial and ethnic under-representation persists and has worsened in mCRPC trials.
- There is a critical need for structural reforms in trial design, funding, and regulatory oversight.
- Equitable access to and generalizability of prostate cancer therapies require improved trial inclusivity.
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