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ACTIVE NOT RECRUITING
NCT00261456

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

Sponsor: Institute of Cancer Research, United Kingdom

View on ClinicalTrials.gov

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 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.

Official title: The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer: Targeted Screening in Men at Higher Genetic Risk and Controls

Key Details

Gender

MALE

Age Range

40 Years - 69 Years

Study Type

OBSERVATIONAL

Enrollment

3500

Start Date

2005-03

Completion Date

2030-03

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

PSA test

Patients tested for their level of Prostate Specific Antigen.

PROCEDURE

Prostate Biopsy

A Prostate biopsy is given as an option to the patient if their PSA level is raised or at the end of 5 years screening.

Locations (1)

Cancer Genetics Unit, Royal Marsden Hospital

Sutton, Surrey, United Kingdom