Paul Nguyen

Despite the fact that black men face higher rates of prostate cancer and are more at risk of dying from the disease, they are underrepresented in clinical trials. BWH investigators recently identified a potential barrier that may be disproportionately preventing black patients from enrolling in these trials: lab test results.

Clinical trials can offer patients access to cutting-edge treatments with the potential to extend their survival and shape the future standard of care. As of last year, more than 400 prostate cancer clinical trials were being conducted to find interventions for patients. BWH investigators found that nearly half of these studies used laboratory values that varied by race, disproportionately excluding black men. Their results are published in JAMA Oncology.

“Something as simple as a lab-value exclusion criteria may serve as yet another barrier to allowing African-American patients to take part in randomized trials,” said corresponding author Paul Nguyen, MD, of the Department of Radiation Oncology. “We hope that this message will reach researchers who are designing clinical trials and setting entry criteria: We need to be cognizant that the criteria we choose may inadvertently make it harder for African-American patients to participate.”

Lead author Marie Vastola, a research assistant in Radiation Oncology, and her colleagues examined prostate cancer trials collected from Specifically, they investigated the use of two components measured in blood tests – serum creatinine (sCr) and absolute neutrophil count (ANC) – to determine a patient’s eligibility for the trial.

Marie Vastola

sCr is used as a measurement of kidney function, but average levels vary by race. Black patients tend to have higher sCr concentrations than white patients or patients of other races or ethnicities. ANC is measured to determine the health of a patient’s immune system. However, up to 8 percent of black patients may have benign ethnic neutropenia, a condition that decreases ANC levels but does not affect the immune system. Without adjusting for race, both measurements may disproportionately disqualify black patients from a clinical trial.

The team found that 47.9 percent of clinical trials used either sCr alone and/or required an ANC level that would exclude patients with benign ethnic neutropenia – two criteria that resulted in disproportionately excluding black patients from prostate cancer trials.

“Adjusting for race-based differences in clinical trial eligibility criteria may add slight logistical challenges, but these adjustments could prevent qualifying individuals from being excluded from trials solely because of laboratory differences caused by their race,” said Vastola.

5 Responses to “Black Patients More Likely to Be Excluded from Prostate Cancer Trials”

  1. Mel

    Wow….This is interesting to me being an African American women with family members diagnosis with Prostate Cancer. Fortunately they were able to overcome this disease. I hope someone steps up and decides that this is crucial for the Black Males in our communities to be able to be a part of theses clinical trials. They need to have same opportunities as others to be able to participation in these studies to make the risk lower for the African American communities.

    • Marie Vastola

      Thank you for your comment, Mel! We absolutely agree with you and we hope this research will increase awareness among the scientists and doctors who design clinical trials. If people are aware of this barrier and make changes accordingly, we may be able to increase participation among African American men and ensure they have equal access to these trials that could potentially cure or slow the progression of their disease.

  2. Mel

    Interesting………..thanks for sharing. I do hope the criteria for the trials are changed soon.

  3. Gail

    So said, how often African Americans are overlooked of left out of clinical trials, study’s, and treatments. Maybe one day race won’t be a factor in determining the criteria for participation in these life saving measures.

  4. Rita Thompson RN

    We as African Americans tend to have different RBC counts, causing misdiagnosis of anemia as well as ANC… Black men as a rule tend to have higher testosterone levels than their white counterparts as well. These variants in indicies would absolutely affect outcomes of clinical trials if not taken into consideration.


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