The Need for Diversity in Prostate Cancer Clinical Trials

Prostate cancer trials need better representation to improve treatment for all populations and help close persistent health disparities.

By Sneha Tete, Integrated MA, Certified Relationship Coach

Created on Sep 25, 2025

Prostate cancer trials need better representation to improve treatment for all populations and help close persistent health disparities.

Clinical trials are essential in developing new therapies and improving patient outcomes for diseases like prostate cancer. Yet, these clinical trials often do not reflect the populations most affected by the disease. This lack of diversity has significant consequences: it limits our understanding of how treatments work across different groups and perpetuates long-standing health disparities—especially for men from racial and ethnic minority backgrounds.

Understanding the Diversity Gap in Prostate Cancer Trials

Prostate cancer is not an equal-opportunity disease. In the United States, Black men are much more likely to be diagnosed with prostate cancer and suffer worse outcomes compared to white men. Hispanic, Asian, and Native American men also face unique risks and barriers to high-quality care. However, when scientists analyze major clinical studies, the participants tend to be overwhelmingly white and from higher socioeconomic backgrounds.

Clinical trials shape the drugs and therapies available to all patients.
If minority groups are underrepresented in research, critical differences in drug safety, efficacy, and outcomes may be missed.
This underrepresentation can worsen health disparities.

Why Representation in Research Matters

Clinical research findings guide medical practice. When people of color and those from diverse backgrounds are missing from trials, it has wide-ranging consequences:

Treatment responses can differ: Biological factors, genetics, social determinants, and environmental exposures can all influence how individuals respond to specific therapies for prostate cancer.
Side effect risks may not be fully understood: Adverse events could disproportionately affect certain groups, leading to unanticipated complications when treatments become widely available.
Key health disparities remain unsolved: Without data on minority populations, it is harder to develop strategies that specifically address why outcomes differ.
Precision medicine promise is limited: Biomarker-driven and personalized therapies may not benefit everyone equally if trials focus mainly on a narrow subset of people.

Current State of Diversity in Prostate Cancer Clinical Trials

Recent analyses reveal a persistent lack of diversity in prostate cancer research:

Black men represent 13-14% of the U.S. population but only about 6-7% of clinical trial enrollees for prostate cancer treatments.
Hispanic and Latinx men make up around 19% of the population but account for less than 2% of trial participants.
Some clinical trials do not even collect or report participants race or ethnicity, making it hard to gauge true inclusion.
The majority of participants in recent prostate cancer studies—up to 96% in some large trials—have been white men.

The situation is even more stark outside the United States, where representation from Africa, the Caribbean, Latin America, and Asia is minimal. Global phase III and IV trials between 1987 and 2016 included mostly white participants, with many studies neglecting to recruit or report on men from regions highly affected by prostate cancer.

Barriers to Participation by Minority Communities

Many factors contribute to the low enrollment of diverse participants in prostate cancer clinical research. These obstacles are complex, spanning individual, community, medical, and systemic levels.

Historical distrust: Past abuses (such as the Tuskegee Syphilis Study) and ongoing inequities lead to deep distrust of medical research in some minority communities.
Lack of access to trial sites: Many high-quality trials take place at academic medical centers, which may be far from where minority groups live or receive care.
Cultural and language barriers: Trials may lack information, consent forms, or support in relevant languages and may not be sensitive to cultural norms.
Eligibility criteria exclusions: Stringent requirements (e.g., excluding people with certain chronic conditions) can disproportionately disqualify individuals from marginalized groups.
Socioeconomic factors: Transportation costs, time off from work, uninsured status, and fear of financial burden discourage both patients and their families.
Poor awareness: Many people never hear about clinical trials due to insufficient outreach from healthcare providers or trial sponsors.
Provider bias: Doctors may be less likely to offer trial participation to minority patients, sometimes unconsciously assuming low interest or compliance.

Consequences of a Lack of Diversity

This diversity gap is not just an academic issue—it has real consequences in the clinic, with life-and-death implications:

Treatments approved primarily in white patients may not work as well in other populations.
Certain genetic mutations relevant to prostate cancer (e.g., those more common in men of African descent) may be missed in biomarker studies.
Unrecognized side effect profiles for minorities can result in avoidable harm.
Disparities in survival and complications persist.

In other words, the lack of diversity inhibits optimal, evidence-based care for everyone—especially those already at greatest risk.

Why Are Minority Populations at Higher Risk for Prostate Cancer?

Multiple factors combine to raise both the risk and severity of prostate cancer in minority groups:

Black men are more likely to be diagnosed at a younger age and with more aggressive disease.
They are more likely to die from prostate cancer compared to white men.
Socioeconomic status, limited access to care, comorbid health conditions, and genetics all play a role.
Puerto Rican and other Hispanic men in the U.S. also have a disproportionately high incidence and mortality rate.
Asian American, Native American, and other ethnic groups may have distinct vulnerabilities that are less well studied.

Strategies to Improve Representation in Prostate Cancer Trials

Several approaches are being developed and refined to close the diversity gap in clinical research. Some notable strategies include:

Community engagement: Building trust through partnerships with local community organizations, churches, barbershops, and respected leaders.
Improved communication: Offering trial materials in multiple languages, using clear and culturally sensitive messaging, and ensuring literacy-appropriate content.
Reducing logistical barriers: Reimbursing travel and providing flexible scheduling opportunities for participants with competing obligations.
Inclusive eligibility criteria: Reviewing trial requirements so they do not automatically exclude people with comorbidities prevalent in minority populations.
Patient navigation and support: Offering dedicated staff to help trial participants understand procedures, navigate paperwork, and access support services.
Investigator diversity: Recruiting and supporting researchers from underrepresented backgrounds can also foster more trust and awareness in the community.

Example: The IRONMAN Registry

The IRONMAN Registry—an international, population-based study—was created to fill critical knowledge gaps about the impact of race and ethnicity in prostate cancer outcomes. The study’s Diversity Working Group has implemented dedicated strategies to:

Maximize minority recruitment and retention.
Collect and analyze outcome data across diverse populations.
Design trials with input from minority patients and advocates.
Expand site selection to locations serving high-risk communities.

This registry is viewed as a model for integrating diversity-focused research strategies and provides a path forward for future trial design.

Benefits of Greater Diversity in Clinical Trials

Increasing representation in research brings wide-ranging benefits for all parties involved. Key advantages include:

Better understanding of effectiveness: Treatments proven effective and safe in a broader range of patients.
Equitable care: Data-driven interventions to address health disparities and improve survival in at-risk communities.
More precision in personalized medicine: More robust biomarker and genetic data for tailoring therapies to individuals.
Policy and process improvements: Evidence to guide regulatory decisions, insurance coverage, and resource allocation.

Actions Needed: What Can Be Done Now?

Creating a more inclusive future in prostate cancer care requires strong, concrete action. Here are some critical next steps for different stakeholders:

Researchers and sponsors: Make diversity a central goal from trial design through recruitment; publish data on race and ethnicity for all studies.
Healthcare providers: Inform all eligible patients about clinical trial options and recognize personal biases that may impact recruitment.
Healthcare systems and policymakers: Support trials in underserved regions and incentivize effective community partnerships.
Patients and advocates: Raise awareness, ask about participation, and hold institutions accountable for inclusion targets.

With continuous and coordinated pressure, the field can move toward equitable representation—and improved outcomes—for all men affected by prostate cancer.

Frequently Asked Questions (FAQs)

Q: Why is diversity important in prostate cancer clinical trials?

A: Diversity ensures we understand how therapies affect people of different races, ethnicities, ages, and backgrounds. Without diverse participation, new treatments may not be equally effective—or safe—for all patient groups.

Q: What are the main barriers to minority participation in trials?

A: Major barriers include distrust of medical research, lack of trial access, transportation and cost issues, language and cultural differences, and underpromotion of opportunities by healthcare providers.

Q: How can trial sponsors improve diversity?

A: Sponsors should work with community leaders, simplify enrollment, provide comprehensive support, adjust eligibility criteria to include those with common chronic conditions, and be transparent about goals and progress on inclusion.

Q: Will improved diversity benefit all patients?

A: Yes. More representative trials lead to better, safer, and more relevant treatments for everyone with prostate cancer, not just historically overrepresented groups.

Prostate Cancer Clinical Trial Diversity at a Glance

Group	US Population Percentage	% of Trial Participants	Disparity
Non-Hispanic White Men	56.3%	80%+	Overrepresented
Black Men	13.4%	6–7%	Significantly Underrepresented
Hispanic/Latinx Men	19%	<2%	Severely Underrepresented
Other Groups (Asian, Native American, etc.)	~11.3%	Minimal Data	Underrepresented/Unknown

Sources: US Census data, analysis of clinical trial enrollment studies (1987–2016).

Key Takeaways

Diversity in prostate cancer clinical trials is essential for achieving equitable care and maximizing the effectiveness of new treatments for all men.
Current clinical trials severely under-enroll minority participants, especially Black and Hispanic men.
Barriers are complex and multi-level—from patient distrust to system-wide issues like trial site selection and eligibility.
Ongoing initiatives like the IRONMAN Registry offer promising models, but more widespread adoption is needed.
Everyone in the prostate cancer community has a role to play in making clinical research more inclusive and beneficial for all.

References

Author

Sneha TeteBeauty & Lifestyle Writer

Sneha is a relationships and lifestyle writer with a strong foundation in applied linguistics and certified training in relationship coaching. She brings over five years of writing experience to thebridalbox, crafting thoughtful, research-driven content that empowers readers to build healthier relationships, boost emotional well-being, and embrace holistic living.

Read full bio of Sneha Tete