Title
Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN)

Description
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, Jamaica, Nigeria, Norway, Spain, 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 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.

Objective
1. To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally;
2. To assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors;
3. To identify associations between treatment sequences or combinations and overall survival;
4. To define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment;
5. To identify clinical and molecular disease subtypes that predict response to individual treatments, combinations, or sequences.

Treatment 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.

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

Males 21 years of age or older

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

Metastatic hormone sensitive prostate cancer OR Castration resistant prostate cancer

No active systemic treatment for a diagnosis of a second, non-prostate malignancy

Applicable Disease Sites
Prostate

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital