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

Abstract

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.

Conflict of interest statement

Rana R. McKayConsulting or Advisory Role: Janssen, Novartis, Tempus, Exelixis, Pfizer, Bristol-Myers Squibb, Astellas Medivation, Dendreon, Bayer, Sanofi, Merck, Vividion Therapeutics, AstraZeneca, CalitheraResearch Funding: Pfizer, Bayer, Tempus Jelani C. ZarifConsulting or Advisory Role: Riptide Bioscience Elisabeth HeathHonoraria: Bayer, Dendreon, Seattle Genetics, Sanofi, AstraZenecaConsulting or Advisory Role: Agensys, Bayer, Dendreon, Sanofi, AstraZenecaSpeakers' Bureau: SanofiResearch Funding: Tokai Pharmaceuticals, Seattle Genetics, Agensys, Dendreon, Genentech/Roche, Millennium, Celldex, Inovio Pharmaceuticals, Celgene, Zenith Epigenetics, Merck, AstraZeneca, Esanik, Zenith Epigenetics, Oncolys BioPharma, Curemeta, Bristol-Myers Squibb, eFFECTOR Therapeutics, Fortis, Astellas Pharma, Medivation, Ignyta, Synta, Caris Life Sciences, Boehringer Ingelheim, GlaxoSmithKline, Merck Sharp & Dohme, Plexxikon, Corcept Therapeutics, Infinity Pharmaceuticals, Bayer, Modra Pharmaceuticals, Pellficure, Champions Oncology, AIQ Solutions, Novartis, Janssen Research & Development, Mirati Therapeutics, Peloton Therapeutics, Daiichi Sankyo Inc, Calibr, Eisai, Pharmacyclics, Five Prime TherapeuticsTravel, Accommodations, Expenses: Agensys, Bayer, SanofiOther Relationship: Caris Centers of Excellence Franklin W. HuangStock and Other Ownership Interests: GlaxoSmithKline Brandon MahalStock and Other Ownership Interests: Novavax, Moderna TherapeuticsHonoraria: Prostate Health Education Network Kellie PaichConsulting or Advisory Role: Bayer Stacey SimmonsEmployment: NovartisStock and Other Ownership Interests: Pfizer, BayerTravel, Accommodations, Expenses: Novartis, Bayer Clayton YatesStock and Other Ownership Interests: Riptide BioscienceConsulting or Advisory Role: Riptide Bioscience, QED TherapeuticsResearch Funding: Riptide BiosciencePatents, Royalties, Other Intellectual Property: I am a co-inventor on several patents assigned to Riptide Biosciences Philip W. KantoffLeadership: Context TherapeuticsStock and Other Ownership Interests: Placon, Druggablity Technologies, Context Therapeutics, SeerConsulting or Advisory Role: Bavarian Nordic, Janssen, Merck, OncoCellMDX, Genentech/Roche, Tarveda Therapeutics, Druggablity Technologies, Progenity, Context Therapeutics, GE Healthcare, SeerPatents, Royalties, Other Intellectual Property: Method for Predicting the Risk of Prostate Cancer Morbidity and Mortality, Predicting and Treating Prostate Cancer, Methods for Predicting Likelihood of Responding to Treatment, Chromosome Copy Number Gain as a Biomarker of Urothelial Carcinoma Lethality, Drug Combinations to Treat Cancer, Somatic ERCC2 Mutations Correlate with Cisplatin sensitivity in muscle-invasive Urothelial Carcinoma (Patent), Up-to-Date Royalties, Wolters Kluwer Royalties, Methods and Kits for Determining Sensitivity to Cancer Treatment, Composition and Methods for Screening and Diagnosis of Prostate CancerOpen Payments Link: https://openpaymentsdata.cms.gov/physician/55315/summary Daniel J. GeorgeLeadership: Capio BioSciencesHonoraria: Sanofi, Bayer, Exelixis, EMD Serono, OncLive, Pfizer, UroToday, Acceleron Pharma, American Association for Cancer Research, Axess Oncology, Janssen Oncology, Millennium Medical PublishingConsulting or Advisory Role: Bayer, Exelixis, Pfizer, Sanofi, Astellas Pharma, Innocrin Pharma, Bristol-Myers Squibb, Genentech, Janssen, Merck Sharp & Dohme, Myovant Sciences, AstraZeneca, Michael J. Hennessy Associates, Vizuri, Constellation Pharmaceuticals, Physician Education Resource LLCSpeakers' Bureau: Sanofi, Bayer, ExelixisResearch Funding: Exelixis, Janssen Oncology, Novartis, Pfizer, Astellas Pharma, Bristol-Myers Squibb, Acerta Pharma, Bayer, Dendreon, Innocrin Pharma, Calithera Biosciences, Sanofi/AventisTravel, Accommodations, Expenses: Bayer, Exelixis, Merck, Pfizer, Sanofi, Janssen Oncology, UroToday Lorelei A. MucciResearch Funding: Sanofi, Astellas Pharma, Bayer, JanssenNo other potential conflicts of interest were reported.

Figures

FIG 1

IRONMAN study procedures. PROMs, patient-reported outcome measures.

FIG 2

(A) Active and pending IRONMAN sites superimposed over map of prostate cancer mortality by state. (B) Countries with participating international sites worldwide.

FIG 3

Monthly IRONMAN study accrual. Blue, global study wide accrual; teal, international (non-US site) accrual; red, US accrual.