Representation of Black men with mHSPC in clinical trials

EP: 1.The Incidence of Prostate Cancer and Risk of Progression in Black Men

EP: 2.Factors Contributing to Higher Incidence and Worse Outcomes of mHSPC in Black Men

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EP: 3.Representation of Black men with mHSPC in clinical trials

EP: 4.The current treatment landscape of mHSPC

EP: 5.Efficacy outcomes in Black patients from the ARANOTE trial

EP: 6.Safety data on Black patients from ARANOTE

EP: 7.Comparing the safety profile of darolutamide with other androgen receptor inhibitors in Black patients

EP: 8.Outcomes in Black patients receiving darolutamide plus ADT for mHSPC

Multifactorial Causes of Racial Disparities

Clinical Trial Representation

Key Themes:

• Black men are significantly underrepresented in prostate cancer clinical trials (<5% in most studies).
• Many trials fail to provide race-specific data.
• The ARANOTE study achieved 10% representation of Black men.
• Representation is critical for both clinicians and patients to understand treatment applicability.

Key Points for Physicians:

• Consider the racial composition of clinical trials when evaluating evidence.
• Note the stronger evidence base for darolutamide in Black men from ARANOTE.
• Acknowledge limitations in data generalizability when discussing treatment options with patients.

Notable Insights: The 10% representation in ARANOTE, although still below the proportion of Black men in the prostate cancer population, represents a significant improvement over typical enrollment patterns and enables more meaningful subgroup analysis.

Clinical Significance: Improved representation in the ARANOTE study provides a stronger evidence base for treatment decisions in Black men with mHSPC.