Status:
ACTIVE_NOT_RECRUITING
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborating Sponsors:
Cancer Research UK
Royal Marsden NHS Foundation Trust
Conditions:
Prostate Cancer
BRCA Mutation
Eligibility:
MALE
40-69 years
Brief Summary
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...
Detailed Description
Prostate cancer is a significant public health problem. In the EU approximately 200,000 men are diagnosed annually with prostate cancer. There are 24,000 cases per year in England and Wales and 10,000...
Eligibility Criteria
Inclusion
- Male carriers of a known pathogenic BRCA1/2 or Mismatch Repair gene mutations (MSH2, MSH6, MLH1) or men testing negative for a known BRCA1/2/ Mismatch repair mutation (MSH2, MSH6, MLH1) in their family
- Aged between 40-69 years old
- WHO performance status 0-2
- No previous history of prostate cancer
- No previous prostate biopsy for raised PSA
- Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule
- Fully informed, written consent according to ICH/EU GCP and national/local regulations before subject registration.
Exclusion
- Previous cancer with terminal prognosis of less than 5 years
- Previous prostate cancer
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2030
Estimated Enrollment :
3500 Patients enrolled
Trial Details
Trial ID
NCT00261456
Start Date
March 1 2005
End Date
March 1 2030
Last Update
September 26 2025
Active Locations (1)
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1
Cancer Genetics Unit, Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT