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Identification of Men with a genetic predisposition to Prostate Cancer: Targeted Screening in men at higher genetic risk and controls (The IMPACT study)

Not Enrolling

Trial ID:NCT00261456

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Protocol #:17-077

877-DF-TRIAL (877-338-7425)

Condition(s):Prostate Cancer in BRCA1 and BRCA2 Carriers

Phase:Not Applicable

Principal Investigator:Syngal, Sapna

Site Research Nurse(s):Grealish, Rhonda,

Trial Description:
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.

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 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.

Eligibility Requirements:
- Male carriers of a known pathogenic BRCA1/2 mutations or men testing negative for a known BRCA1/2 mutation 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

Protocol #: 17-077

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