International Registry for Men With Advanced Prostate Cancer (IRONMAN)

(IRONMAN Trial)

Recruiting at 112 trial locations

Overseen By Jacob Vinson

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Prostate Cancer Clinical Trials Consortium

Disqualifiers: Non-prostate malignancy requiring therapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

5000 Participants Needed

Trial Summary

What is the purpose of this trial?

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

Research Team

Daniel George, MD

Principal Investigator

Duke Cancer Institute

Lorelei Mucci, ScD

Principal Investigator

Harvard School of Public Health (HSPH)

Phillip Kantoff, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide written informed consent and privacy authorization for the release of personal health information.

NOTE: Privacy authorization may be either included in the informed consent or obtained separately.

Males 21 years of age and above

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Detailed data collection from patients at study enrollment, including blood samples and PROMs questionnaires

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for overall survival, adverse events, comorbidities, changes in cancer treatments, and PROMs for a minimum of five years

5 years

Quarterly visits (virtual or in-person)

Biomarker Collection

Collection of blood samples and existing tumor tissue for research on treatment response and resistance

Ongoing

Treatment Details

Interventions

• Standard of Care

Participant Groups

Group I: Hormone Sensitive Prostate Cancer Experimental Treatment 1 Intervention

Group II: Castrate Resistant Prostate Cancer Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Prostate Cancer Clinical Trials Consortium

Lead Sponsor

Trials

12

Recruited

7,400+