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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151629
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Prostate Cancer Clinical Trials Consortium

Tracking Information
First Submitted Date May 10, 2017
First Posted Date May 12, 2017
Last Update Posted Date February 10, 2020
Actual Study Start Date May 1, 2017
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2017)
Practice Patterns [ Time Frame: 5 years ]
To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)
Official Title Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)
Brief Summary

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, 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 three 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, every three months for the first and second year then every six months.

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. 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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Metastatic hormone sensitive prostate cancer (mHSPC): Prostate cancer patients diagnosed with histologically confirmed cancer with radiological evidence of metastatic disease and on ADT for no more than 90 days.

Castration resistant prostate cancer (CRPC): Prostate cancer patients (with or without radiological evidence of metastatic disease) with a confirmed rising PSA (at least two measures) while on ADT or orchiectomy or castrate level of testosterone as determined by investigator.

Prostate cancer patients with mixed histological types may participate in this Registry.

Condition Prostate Cancer
Intervention Other: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
Study Groups/Cohorts
  • Castrate Resistant Prostate Cancer
    Intervention: Other: Standard of Care
  • Hormone Sensitive Prostate Cancer
    Intervention: Other: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 11, 2017)
5000
Original Actual Enrollment Same as current
Estimated Study Completion Date June 2024
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Men
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jacob Vinson 646-888-0421 pcctcironmanregistry@mskcc.org
Listed Location Countries Australia,   Brazil,   Canada,   Ireland,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03151629
Other Study ID Numbers c16-170
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Prostate Cancer Clinical Trials Consortium
Study Sponsor Prostate Cancer Clinical Trials Consortium
Collaborators Not Provided
Investigators
Principal Investigator: Daniel George, MD Duke Cancer Institute
Principal Investigator: Lorelei Mucci, ScD Harvard School of Public Health
Principal Investigator: Phillip Kantoff, MD Memorial Sloan Kettering Cancer Center
PRS Account Prostate Cancer Clinical Trials Consortium
Verification Date October 2019