Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
329 participants
OBSERVATIONAL
2016-04-29
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Stage 1
Caucasian men aged 55-69 to undergo genetic profiling.
Genetic SNP profiling
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
Stage 2
Men from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer.
Genetic SNP profiling
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
Prostate cancer screening
Prostate cancer screening in the form of PSA testing will be offered to all men who have a benign biopsy result for five years in order to track development of cancer in the future.
Prostate biopsy
Prostate biopsy will be offered to men identified within the top 10% genetic risk score profile.
Interventions
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Genetic SNP profiling
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
Prostate cancer screening
Prostate cancer screening in the form of PSA testing will be offered to all men who have a benign biopsy result for five years in order to track development of cancer in the future.
Prostate biopsy
Prostate biopsy will be offered to men identified within the top 10% genetic risk score profile.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Caucasian ethnicity
* World Health Organisation (WHO) performance status 0-2
* Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule
Exclusion Criteria
* Previous diagnosis of cancer with a life-expectancy of less than five years
* Prostate biopsy in the past year
* Previous diagnosis of prostate cancer
* Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication like Warfarin or Clopidogrel, poorly controlled diabetes or cardiovascular disease)
55 Years
69 Years
MALE
Yes
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Rosalind A Eeles, FRCP, FRFR
Role: PRINCIPAL_INVESTIGATOR
Institute of Cancer Research and Royal Marsden Hospital
Locations
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Institute of Cancer Research and Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Countries
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Other Identifiers
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CCR4130
Identifier Type: -
Identifier Source: org_study_id
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