Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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

- Histological or cytological confirmed prostate adenocarcinoma from TRUS biopsy,
radical prostatectomy or TURP Or Documented histopathology or cytopathology of
prostate adenocarcinoma from a biopsy of a metastatic site Or Metastatic disease
typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic
lymph nodes) AND a serum concentration of PSA >20ng/mL

- No previous diagnosis of a second, non-prostate malignancy that requires additional
systemic therapy except cancer in situ of bladder and basal cell cancer of skin

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Castrate Resistant Prostate Cancer
  • Other: Standard of Care
    Drugs routinely administered for metastatic prostate cancer per local standard.
Hormone Sensitive Prostate Cancer
  • Other: Standard of Care
    Drugs routinely administered for metastatic prostate cancer per local standard.

Recruiting Locations

Tulane University
New Orleans, Louisiana 70118
Contact:
Pedro Barata, MD

Tulane University
New Orleans, Louisiana 70112

More Details

NCT ID
NCT03151629
Status
Recruiting
Sponsor
Prostate Cancer Clinical Trials Consortium

Study Contact

Jacob Vinson
646-888-0421
pcctcironmanregistry@mskcc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.