The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Primary completion date: Feb 28, 2025 to Feb 28, 2030
    • Study completion date: Feb 2030 to Mar 2030
    v17
  2. Re-verified, no change to tracked fieldsv16
  3. Enrollment target: estimated 1700 to confirmed 3500v15 Show 5 more changesShow less
    • Interventions: PSA test (Behavioral), Prostate Biopsy (Procedure) to PSA test (Diagnostic Test), Prostate Biopsy (Procedure)
    • Eligibility criteria expanded, about 12 words
    • Collaborators: 3 to 4
    • Publications: 11 to 14
    • Study arms: 2 to 4
  4. 2 versions Re-verified since Mar 30, 2022, no change to tracked fieldsv13-v14
  5. Primary completion date: Feb 29, 2020 to Feb 28, 2025v12 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Feb 2025 to Feb 2030
    • Site details revised
    • Publications: 8 to 11
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Dec 2019 to Feb 29, 2020
    • Study completion date: Dec 2024 to Feb 2025
    • Start date: Oct 2005 to Mar 2005
    v11
  2. Study completion date: Dec 2021 to Dec 2024v10
  3. 4 versions Re-verified since Aug 31, 2016, no change to tracked fieldsv6-v9
  4. Primary completion date: Dec 2016 to Dec 2019
    • Study completion date: Dec 2017 to Dec 2021
    • Publications: 4 to 8
    v5
  5. Primary completion date: Dec 2012 to Dec 2016v4
  6. Primary completion date: Dec 2012
    • Study completion date: Oct 2020 to Dec 2017
    • Publications: 3 to 4
    v3
  7. Interventions: PSA test (Behavioral), Prostate Biopsy (only if raised PSA level) (Procedure) to PSA test (Behavioral), Prostate Biopsy (Procedure)
    • Site contact updated
    • Study arms: 0 to 2
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The IMPACT study is an international targeted prostate screening study of men at increased prostate cancer risk due to the presence of known pathogenic mutations in BRCA1 and BRCA2 genes and Mis-Match Repair genes (MLH1, MSH6, MSH2). There are only approximately 150 men with a known BRCA1 or BRCA2 mutation in the UK. Research has shown that these men are at an increased risk of developing prostate cancer but more information is needed about the pathogenesis of prostate cancer in this defined group and the role of screening in these men. The study will offer annual PSA screening to these men to determine the incidence of prostate cancer in this group. The study will also look at new markers of early prostate cancer in this cohort. The power calculations for this study are 850 carriers and 850 controls (age-matched men without BRCA1/2. Mis match repair mutations). It is therefore essential to gain international collaboration to meet the target of recruiting 850 men with these known mutations and a control group of 850 men who have tested negative for a known familial mutation.
Trial Details
NCT Number NCT00261456
Lead Sponsor Institute of Cancer Research, United Kingdom
Collaborators: Cancer Research UK, Royal Marsden NHS Foundation Trust, Ronald and Rita McAulay Foundation, BRCA Research and Cure Alliance
Conditions
(from sponsor)		 Prostate Cancer, BRCA Mutation, Mismatch Repair Gene Mutation, Genetic Predisposition to Disease
Related terms Colorectal Neoplasms, Hereditary Nonpolyposis, Genetic Predisposition to Disease, Prostatic Neoplasms
Enrollment 3,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov