Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry.

Prostate cancer disproportionately affects racial and ethnic minority populations. Reasons for disparate outcomes among minority patients are multifaceted and complex, involving factors at the patient, provider, and system levels.

Although advancements in our understanding of disease biology have led to novel therapeutics for men with advanced prostate cancer, including the introduction of biomarker-driven therapeutics, pivotal translational studies and clinical trials are underrepresented by minority populations. Despite attempts to bridge the disparities gap, there remains an unmet need to expand minority engagement and participation in clinical trials to better define the impact of therapy on efficacy outcomes, quality of life, and role of biomarkers in diverse patient populations. The IRONMAN registry (ClinicalTrials.gov identifier: NCT03151629), a global, prospective, population-based study, was borne from this unmet medical need to address persistent gaps in our knowledge of advanced prostate cancer. Through integrated collection of clinical outcomes, patient-reported outcomes, epidemiologic data, and biospecimens, IRONMAN has the goal of expanding our understanding of how and why prostate cancer outcomes differ by race and ethnicity. To this end, the Diversity Working Group of the IRONMAN registry has developed informed strategies for site selection, recruitment, engagement and retention, and trial design and eligibility criteria to ensure broad inclusion and needs awareness of minority participants. In concert with systematic strategies to tackle the complex levels of disparate care, our ultimate goal is to expand minority engagement in clinical research and bridge the disparities gap in prostate cancer care.

JCO global oncology. 2021 Apr [Epub]

Rana R McKay, Theresa Gold, Jelani C Zarif, Ilkania M Chowdhury-Paulino, Adam Friedant, Travis Gerke, Marie Grant, Kelly Hawthorne, Elisabeth Heath, Franklin W Huang, Maria D Jackson, Brandon Mahal, Osarenren Ogbeide, Kellie Paich, Camille Ragin, Emily M Rencsok, Stacey Simmons, Clayton Yates, Jake Vinson, Philip W Kantoff, Daniel J George, Lorelei A Mucci

Moores Cancer Center, University of California San Diego, La Jolla, CA., Prostate Cancer Clinical Trials Consortium, New York, NY., Johns Hopkins University School of Medicine, Baltimore, MD., Harvard University, Boston, MA., Moffitt Cancer Center, Tampa, FL., Movember Foundation, East Melbourne, Victoria, Australia., Karmanos Cancer Center, Detroit, MI., University of California San Francisco, San Francisco, CA., University of the West Indies, Mona, Kingston, Jamaica, West Indies., University of Miami, Miami, FL., University of Tennessee, Memphis, TN., Fox Chase Cancer Center, Philadelphia, PA., Bayer Healthcare Pharmaceutical, Wayne, NJ., Tuskegee University, Tuskegee, AL., Memorial Sloan Kettering Cancer Center, New York, NY., Duke University, Durham, NC.

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