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Health Condition(s) or Problem
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Prostate Cancer in BRCA1 and BRCA2 Carriers
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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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
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Primary aim
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Sorry, not currently available
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Secondary Aim
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Sorry, not currently available
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://www.impact-study.co.uk; http://www.cancerhelp.org.uk/trials/trials/trial.asp?
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Sutton
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