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Clinical Trial 20010

Cancer Type: Genitourinary
Study Type: Other
NCT#: NCT03151629

Phase: N/A
Prinicipal Investigator: Kosj Yamoah

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or 1-800-679-0775 Learn More
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.

Treatments

Therapies

Medications

Inclusion 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

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