Real-World Representation in Prostate Cancer Clinical Trials: Needs and Opportunities.

Area of Science:

• Oncology
• Clinical Trials
• Health Disparities

Background:

• Prostate cancer (PC) care has advanced significantly, improving survival for metastatic disease.
• A gap exists between clinical trial data and real-world patient populations regarding efficacy and toxicity.
• Modern PC therapies, especially for metastatic hormone-sensitive PC, face slow adoption due to trial population underrepresentation.

Purpose of the Study:

• To review strategies for enhancing clinical trial populations in prostate cancer research.
• To address the underrepresentation of key patient groups in PC clinical trials.
• To improve the real-world applicability of modern PC therapies.

Main Methods:

• Review of existing literature on prostate cancer clinical trials.
• Analysis of underrepresented populations in PC trials (older adults, comorbidities, rural, non-European ancestry).
• Proposal of strategies to diversify future PC trial cohorts, focusing on later-phase studies.

Main Results:

• Key populations like older adults, those with comorbidities, rural individuals, and non-European ancestry are underrepresented in PC trials.
• This underrepresentation limits understanding of real-world effectiveness and adverse events.
• It also hinders the discovery of ancestry-related biomarkers.

Conclusions:

• Diversifying clinical trial populations is crucial for equitable and effective prostate cancer care.
• Strategies are proposed to ensure future trials better reflect the diverse patient population.
• Broader adoption of modern therapies and biomarker discovery depend on inclusive trial designs.