International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of Care — OTHER
  Drugs routinely administered for metastatic prostate cancer per local standard.

Study Details

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.

Key Dates

Start date

Jul 21, 2017

Status verified

May 2026

Primary completion

Jan 31, 2031

Completion

Jan 31, 2032

Study Design

Enrollment

5,000 participants (estimated)

Arms

• Arm: Castrate Resistant Prostate Cancer
• Arm: Hormone Sensitive Prostate Cancer

Primary Outcome Measure

Practice Patterns [ Time Frame: 5 years ]

Central Contacts

• Jacob Vinson
  646-888-0421
  [email protected]

Locations (48)

Find similar trials in Birmingham, AL

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