International registry for men with advanced prostate cancer
International Registry for Men With Advanced Prostate Cancer (IRONMAN)
This study is creating a global registry of at least 5,000 men with advanced prostate cancer to see how their care and treatment differ around the world.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 21 Years and up |
| Sex | Male |
| Sponsor | Prostate Cancer Clinical Trials Consortium Academic / other |
| Locations | 121 sites (Birmingham, Alabama and 120 other locations) |
| Trial ID | NCT03151629 on ClinicalTrials.gov |
What this trial studies
The IRONMAN initiative aims to create a prospective international registry of at least 5,000 men diagnosed with advanced prostate cancer, including those with metastatic hormone-sensitive prostate cancer (mHSPC) and castration-resistant prostate cancer (CRPC). This observational study will recruit participants from various academic and community practices across multiple countries, including the US, UK, and several others. Detailed data will be collected at enrollment and during follow-up to understand the variations in care and treatment for advanced prostate cancer globally.
Who should consider this trial
Good fit: Ideal candidates include males aged 21 and older with confirmed prostate adenocarcinoma and specific disease characteristics.
Not a fit: Patients with a previous diagnosis of a second malignancy requiring systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could lead to improved understanding and treatment outcomes for men with advanced prostate cancer.
How similar studies have performed: Other studies have shown success with similar registry approaches, indicating potential for valuable insights in prostate cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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 at the time of initial prostate cancer diagnosis * 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
Where this trial is running
Birmingham, Alabama and 120 other locations
- University of Alabama-Birmingham — Birmingham, Alabama, United States (Completed)
- University of Alabama- Tuscaloosa — Tuscaloosa, Alabama, United States (Recruiting)
- University of California - Los Angeles — Los Angeles, California, United States (Terminated)
- University of California San Diego — San Diego, California, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Terminated)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Morehouse School of Medicine — Atlanta, Georgia, United States (Recruiting)
- Emory Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Kishwaukee Cancer Center — DeKalb, Illinois, United States (Recruiting)
- Delnor Cancer Center — Geneva, Illinois, United States (Recruiting)
- Warrenville Cancer Center — Warrenville, Illinois, United States (Recruiting)
- Tulane University — New Orleans, Louisiana, United States (Active_not_recruiting)
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
- Chesapeake Urology Associates — Towson, Maryland, United States (Terminated)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Terminated)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Active_not_recruiting)
- VA Western New York Healthcare System — Buffalo, New York, United States (Terminated)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Weill Cornell Medical Center — New York, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Durham VA Medical Center — Durham, North Carolina, United States (Recruiting)
- Duke Cancer Network — Durham, North Carolina, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Oregon Health & Science University Hospital — Portland, Oregon, United States (Recruiting)
- Doylestown Health — Doylestown, Pennsylvania, United States (Completed)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Active_not_recruiting)
- Fox Chase Cancer Center - Temple Health — Philadelphia, Pennsylvania, United States (Recruiting)
- Reading Health System — West Reading, Pennsylvania, United States (Recruiting)
- Ralph H. Johnson VA Medical Center — Charleston, South Carolina, United States (Recruiting)
- William Jennings Bryan Dorn VAMC — Columbia, South Carolina, United States (Terminated)
- Memphis VA Medical Center — Memphis, Tennessee, United States (Recruiting)
- Baptist Clinical Research Institute — Memphis, Tennessee, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Completed)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
- University of Washington Medical Center — Seattle, Washington, United States (Active_not_recruiting)
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)
- Royal Brisbane & Women's Hospital — Herston, Brisbane, Australia (Recruiting)
- St. Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
+71 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Daniel George, MD — Duke Cancer Institute
- Study coordinator: Jacob Vinson
- Email: pcctcironmanregistry@mskcc.org
- Phone: 646-888-0421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.