Clinical Trial 20010

• Overview

  Study Title:

  IRONMAN: International Registry for Men with Advanced Prostate Cancer

  Summary:

  The purpose of this study is to learn more about prostate cancer and to describe the use of different therapies for advanced prostate cancer internationally; to describe specific treatment patterns and whether they are associated with differences in outcomes such as hospitalizations; to identify associations between treatment sequences or combinations and overall survival; to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment; and to identify clinical and molecular disease subtypes that may predict for a reduction in cancer from individual treatments, combinations, or sequences.

  Objective:

  The IRONMAN Registry investigators intend to create an international, population-based, prospective registry of minimum 5,000 men with advanced prostate cancer. Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. The IRONMAN Registry aims to collect detailed clinical, epidemiological and biological information about these patients at study enrollment and to follow them prospectively with the following objectives: 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 OS; 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.

• Inclusion Criteria

  • Willing and able to provide written informed consent and privacy authorization for the release of personal health nformation. Individuals classified as "adults lacking decision-making capacity" are permitted to be enrolled in this study as long they can complete the study procedures. Individuals lacking capacity wishing to enroll should be consented by their legally authorized representative (LAR) and the LAR should fill out the applicable section on the IRONMAN consent form. 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 at time of initial prostate cancer diagnosis. Note: variant histologies are allowed.
  • Metastatic hormone sensitive prostate cancer (mHSPC): a) Metastatic disease M1a, b, or c stage as defined by the American Joint Committee on Cancer at diagnosis, or progressing to mHSPC after localized disease diagnosis b) No more than 90 days of active systemic therapy (including ADT) at the time of consent. NOTE: If patient received ADT (for any length of time) prior to current systemic therapy, documented recovery of testosterone (as determined by investigator) is required.
  • Castration resistant prostate cancer (CRPC): ) A rising PSA indicating progressing disease or new metastatic disease as determined by the investigator while on ADT (or orchiectomy) or with castrate level of testosterone as determined by investigator b) No more than 90 days of continuous life prolonging (in the opinion of the investigator) systemic therapy for CRPC at the time of consent. NOTE: Prior systemic therapy for any length of time for mHSPC is allowed for patients currently with CRPC. NOTE: Continued ADT in the castration resistant setting is allowed. NOTE: Patients enrolling to the c16-170a PRODIGY sub-study with greater than 90 days of continuous life prolonging therapy for CRPC who are otherwise eligible for IRONMAN and the PRODIGY sub-study are exempt from this requirement.
  • No current or prior non-prostate cancer requiring systemic therapy within the last two years.
  • For both mHSPC and CRPC, prior treatment with prior treatment with bisphosphonates or denosumab will be permitted.

• Exclusion Criteria

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