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.

JCO Oncology Practice
|November 24, 2025
PubMed
Abstract

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.

Related Concept Videos

Disorders of the Male Reproductive System01:20

Disorders of the Male Reproductive System

Men's health issues are increasingly recognized as significant, with several conditions posing common threats. Among these, testicular cancer is especially prevalent in younger men, particularly those aged 20 to 35 years. The disease often manifests as a painless mass in the testicles, sometimes accompanied by a sensation of heaviness or a dull ache.
Prostate disorders are another major concern. These conditions can impair urinary flow due to the prostate's location around the urethra....
3.9K
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against...
8.6K
Treatment Resistant Cancers02:56

Treatment Resistant Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
3.7K