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

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ClinicalTrials.gov Identifier: NCT03151629
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Prostate Cancer Clinical Trials Consortium

Study Description
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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.


Condition or disease Intervention/treatment
Prostate Cancer Other: Standard of Care

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prostate Cancer Outcomes: An International Registry to Improve Outcomes in Men With Advanced Prostate Cancer (IRONMAN)
Actual Study Start Date : July 21, 2017
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Castrate Resistant Prostate Cancer Other: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
Hormone Sensitive Prostate Cancer Other: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.


Outcome Measures
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Primary Outcome Measures :
  1. Practice Patterns [ Time Frame: 5 years ]
    To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men
Accepts Healthy Volunteers:   No
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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151629


Contacts
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Contact: Jacob Vinson 646-888-0421 pcctcironmanregistry@mskcc.org

Locations
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Sponsors and Collaborators
Prostate Cancer Clinical Trials Consortium
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Prostate Cancer Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT03151629    
Other Study ID Numbers: c16-170
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases