Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer (PEACE-4)
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ClinicalTrials.gov Identifier: NCT03819101 |
Recruitment Status :
Recruiting
First Posted : January 28, 2019
Last Update Posted : February 14, 2023
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Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 24, 2019 | ||||||||
First Posted Date ICMJE | January 28, 2019 | ||||||||
Last Update Posted Date | February 14, 2023 | ||||||||
Actual Study Start Date ICMJE | June 6, 2019 | ||||||||
Estimated Primary Completion Date | March 2034 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Overall Survival (OS) [ Time Frame: OS will be calculated from the date of randomization to the date of death up to 15 years ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer | ||||||||
Official Title ICMJE | A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer | ||||||||
Brief Summary | This is a 2x2 factorial randomized, multicenter, international, open phase III trial. The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Intervention Model Description: This is a 2x2 factorial randomized, multicenter, international, open phase III trial Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* 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 ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
1210 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | March 2038 | ||||||||
Estimated Primary Completion Date | March 2034 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France, Switzerland | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03819101 | ||||||||
Other Study ID Numbers ICMJE | 2017-004639-35 2017/2601 ( Other Identifier: CSET number ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Gustave Roussy, Cancer Campus, Grand Paris | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Gustave Roussy, Cancer Campus, Grand Paris | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | National Cancer Institute, France | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Gustave Roussy, Cancer Campus, Grand Paris | ||||||||
Verification Date | February 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |