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Diversity in Clinical Trials for Prostate Cancer

Men of Color are Underrepresented in Prostate Cancer Clinical Trials

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What exactly is a clinical trial and why are they important in prostate cancer?

Clinical trials are research studies that involve people to determine if treatments are safe and effective. When carefully conducted, clinical trials are the safest and fastest way to find new treatments and ways to improve people’s health. They are also important in improving existing treatments and the quality of life of people living with diseases.

Although early stage prostate cancer has high survival rates, advanced disease is more difficult to treat.  Therefore, research and trials are critical in the treatment of prostate cancer, especially for metastatic castration-resistant prostate cancer (mCRPC) if the cancer progresses after standard therapies.  Trials such as Taiho’s Phase 1 study of TAS3681 (an oral molecule in development for the potential treatment of prostate cancer) are important to be able to assess  safety and other aspects of this investigative agent in the treatment of prostate cancer. 

More information about prostate cancer treatments is available on the ZERO website here, from the American Cancer Society and the National Cancer Institute.

Why is diversity in clinical trials important?

Medicines impact people differently. Therefore, some subgroups of patients may have varied responses to medical therapies. Ideally, a clinical trial should include a diverse set of participants to ensure that the people in the trial are representative of the patients who will actually use the medicine.  Unfortunately, ethnically and racially diverse audiences are underrepresented in clinical trials. While Black or African Americans make up 13.4% of the U.S. population, they only make up 5% of trial participants.,

Prostate Cancer Trials & Diversity

Specifically with prostate cancer, trial participants continue to be mostly white despite the fact that African American men are disproportionately impacted by prostate cancer. And the number of black men participating in prostate clinical trials is getting lower according to a study published in Cancer Epidemiology, Biomarkers, & Prevention in June 2020.6  

The study states that the inclusion of African American men in prostate cancer trials has decreased from 11.3% in 1995 to 2.8% in 2014.5 Moreover, of 59 prostate cancer clinical trials based in North America and Europe, the vast majority of enrollees were white men.6

Where can I find out more information about clinical trials? 

The good news is there are a lot of places to find a clinical trial. A great place to learn more about what it means to be part of clinical trial is to visit clinical-trials/. You can also search for specific trials at or via the National Cancer Institute’s database at

  1.  FDA website. 24SEPT2021
  2. Urology Times. Emerging treatment options for the management of metastatic castration-resistant prostate cancer. Sept 7, 2021.
  3.  Luther T.Clark MD, Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Current Problems in Cardiology, Volume 46, Issue 3, March 2021, Pages 100647
  4.  Yates, Isabelle, Representation in Clinical Trials: A Review on Reaching Underrepresented Populations in Research.  Clinical Researcher—August 2020 (Volume 34, Issue 7).
  5. FDA Drug Snapshot Report 2020(
  6. Cancer Epidemiology, Biomarkers & Prevention. Diversity of Enrollment in Prostate Cancer Clinical Trials: Current Status and Future Directions. July 2020. Volume 29, Issue 7

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Written by Stacey Bilinsky. Stacey Bilinski is the Sr. Director, Clinical Operations at Taiho Oncology Inc. where she oversees several oncology compounds in development including a study in prostate cancer. She provides leadership for clinical operations with over 30 years of experience in clinical trials and clinical operations including executing clinical trials, managing study teams and vendors to execute studies and deliver final results for submission.