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

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.

Sex

Male

Minimum age

40 Years

Maximum age

69 Years

Inclusion Criteria:

* 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 Criteria:

* Previous cancer with terminal prognosis of less than 5 years
* Previous prostate cancer

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