NCT00261456Active, not recruiting
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer: Targeted Screening in Men at Higher Genetic Risk and Controls
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 3500 (actual)
- First submitted
- 1 Dec 2005
- Start date
- Mar 2005
- Primary completion date
- 28 Feb 2030
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Diseases
- Prostate cancer
- NCT number
- NCT00261456
What you commit to
- Study type: Observational
- Participants enrolled: 3500
- From Mar 2005 to the primary completion date, 28 Feb 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate cancer
Other illness
- Previous cancer with terminal prognosis of less than 5 years
Who the study is looking for
- 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.
Age in the registry: 40 years to 69 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Genetics Unit, Royal Marsden Hospital Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.