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 |
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Recruitment Status :
Recruiting
First Posted : May 12, 2017
Last Update Posted : September 18, 2020
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| Tracking Information | ||||||||||
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| First Submitted Date | May 10, 2017 | |||||||||
| First Posted Date | May 12, 2017 | |||||||||
| Last Update Posted Date | September 18, 2020 | |||||||||
| Actual Study Start Date | July 21, 2017 | |||||||||
| Estimated Primary Completion Date | January 2029 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Practice Patterns [ Time Frame: 5 years ] To describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally
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| 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. |
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| Detailed Description | Not Provided | |||||||||
| Study Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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. |
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| Condition | Prostate Cancer | |||||||||
| Intervention | Other: Standard of Care
Drugs routinely administered for metastatic prostate cancer per local standard.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
5000 | |||||||||
| Original Actual Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | January 2029 | |||||||||
| Estimated Primary Completion Date | January 2029 (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.
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| Sex/Gender |
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| Ages | 21 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Prostate Cancer Clinical Trials Consortium | |||||||||
| Study Sponsor | Prostate Cancer Clinical Trials Consortium | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Prostate Cancer Clinical Trials Consortium | |||||||||
| Verification Date | September 2020 | |||||||||