International Registry for Men With Advanced Prostate Cancer (IRONMAN)

  • STATUS
    Recruiting
  • End date
    Jan 2, 2029
  • participants needed
    5000
  • sponsor
    Prostate Cancer Clinical Trials Consortium
Updated on 2 September 2021
castration-resistant prostate cancer

Summary

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, Brazil, Canada, Ireland, Sweden, Switzerland, the United Kingdom (UK), and the 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 three 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, every three months for the first and second year then every six months.

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. 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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Standard of Care
Clinical Study IdentifierNCT03151629
SponsorProstate Cancer Clinical Trials Consortium
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males of any race between 35 and 55 years of age
Body mass index between 18.0 and 30.0 kg/m2
In good health
Males will agree to use contraception
Able to comprehend and sign an informed consent form
History of a minimum of 1 bowel movement per day

Exclusion Criteria

History of significant medical illness
History of clinically significant drug allergy
History of a seizure disorder, not including infantile seizures
History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs
Clinically significant medical treatment within 8 weeks or infection treatment within 4 weeks of dosing
Clinically significant ECG abnormality
History of alcoholism or drug/chemical abuse within the previous 2 years or positive screening test
Significant alcohol consumption
Positive hepatitis panel and/or positive human immunodeficiency virus test
Use of prohibited prescription, over-the-counter medications or natural health products
Use of tobacco or nicotine-containing products within 3 months prior to Check-in or positive screening test
Receipt of blood products within 2 months prior to Check in
Recent donation of blood, plasma, or platelets prior to Screening
Exposure to significant diagnostic, therapeutic or employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
Evidence or history of active suicidal thoughts in the previous 5 years or have any lifetime history of a suicide attempt
Not suitable for study in the opinion of the Principal Investigator
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