International Registry for Men With Advanced Prostate Cancer (IRONMAN)


About this study

The purpose of this registry is to collect detailed clinical, epidemiological and biological information from 5,000 male patients with advanced prostate cancer.

The objectives are to describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally; to assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors; 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 predict response to individual treatments, combinations, or sequences.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Willing and able to provide written informed consent and privacy authorization for the release of personal health information.
  • Males 21 years of age and above.
  • 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 > 20ng/mL:
    • Variant histologies are allowed.
  • Have either Metastatic hormone sensitive prostate cancer (mHSPC):
  • Metastatic disease M1a, b, or c stage as defined by the American Joint Committee on Cancer; and
  • 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; or
  • 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.
    • 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.
  • No current or prior non-prostate cancer requiring systemic therapy within the last two years.
  • For both mHSPC and CRPC, prior treatment with bisphosphonates or denosumab will be permitted.

Exclusion Criteria:

  • Not able to provide written informed consent and privacy authorization.
  • Females and/or 21 years of age and lower.
  • Have a prostate cancer diagnosis/prognosis not listed in the inclusion criteria.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Folakemi Odedina, Ph.D.

Open for enrollment

Contact information:

Nicole Fitzgibbon

More information


Publications are currently not available

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