The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer | Recruiting
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Health Conditions
  • Prostate Cancer in BRCA1 and BRCA2 Carriers
Recruiting
Recruitment Status
NCT00261456
Primary Trial ID Number
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. 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.
Primary Outcome Measures
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Secondary Outcome Measures
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Research Question
  • 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.
Design Type
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Ethics Approval
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Publications
Tischkowitz M, Eeles R; IMPACT study: Identification of Men with genetic predisposition to Prostate Cancer and its Clinical Treatment collaborators. Mutations in BRCA1 and BRCA2 and predisposition to prostate cancer. Lancet. 2003 Jul 5;362(9377):80; author reply 80.; 12853213
Countries of Recruitment
United Kingdom
Participant Sex
Male
Participant Age Range
40 Years to 69 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
1700
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - 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
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - 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
Interventions
Behavioral; PSA test; Patients tested for their level of Prostate Specific Antigen.; [BRCA1/2 carriers, BRCA1/2/non Carriers]; 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.; [BRCA1/2 carriers, BRCA1/2/non Carriers]
Design Details
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Study Design
Observational Model: Case Control, Time Perspective: Prospective
Results Reporting
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Acronym
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Scientific Title
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer: Targeted Screening in BRCA1/2 Mutation Carriers & Controls
Secondary Trial Identifying Number
CCR2598
Website
http://www.impact-study.co.uk; http://www.cancerhelp.org.uk/trials/trials/trial.asp?
Study Funded By
Institute of Cancer Research, United Kingdom
Funder Type
Sorry, this information is not available
Study Sponsored By
Institute of Cancer Research, United Kingdom
Study Also Sponsored By
Cancer Research UK; Royal Marsden NHS Foundation Trust; Ronald and Rita McAulay Foundation
Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

01 Dec 2005

Last Updated

13 Jul 2015

Date Record Refreshed on UKCTG

01 Aug 2015