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

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.

Conditions

• Prostate Cancer
• BRCA Mutation
• Mismatch Repair Gene Mutation
• Genetic Predisposition to Disease

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.

Sponsors & Collaborators

• Cancer Research UK

  collaborator OTHER

• Royal Marsden NHS Foundation Trust

  collaborator OTHER

• Ronald and Rita McAulay Foundation

  collaborator UNKNOWN

• BRCA Research and Cure Alliance

  collaborator UNKNOWN

• Institute of Cancer Research, United Kingdom

  lead OTHER

Principal Investigators

• Rosalind A Eeles, FRCP FRCR · Institute of Cancer Research and Royal Marsden Hospital

Eligibility

Min Age

40 Years

Max Age

69 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-03-31

Primary Completion

2030-02-28

Completion

2030-03-31

Countries

• United Kingdom

Study Locations