Precision Medicine in the Prostate Cancer Care Pathway: an Evaluation of Integrating Germline Genetic Testing Into the Management of Men at Risk of / Living With Prostate Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Institute of Cancer Research, United Kingdom
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Prevalence of genetic variation in affected men
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This study aims to evaluate the use of a prostate cancer specific predisposition genetic panel test in men with / at high risk of prostate cancer. The genetic test will analyse men's DNA samples for the presence of mutations in rare genes as well as common genetic variation to provide men with information about their risk of prostate cancer. This study will evaluate the clinical impact of the test on risk assessment and clinical management in terms of screening and treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Affected cohort:
- •Affected with PrCa \< 60 years or
- •Affected with metastatic castration resistant PrCa (mCRPC) at any age or Aggressive PrCa Gleason 4+4 or higher \<70 years
- •Affected with family history defined as three or more cases any age (FDR or SDR)
- •Unaffected cohort: (This cohort is no longer recruiting, it has completed recruitment)
- •Aged \>30 and with a family history defined as:
- •FDR diagnosed \< 70
- •2 or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed \< 70 years
- •3 or more cases at any age (on same side of family)
Exclusion Criteria
- •• WHO performance status 4
Outcomes
Primary Outcomes
Prevalence of genetic variation in affected men
Time Frame: Through study completion, an average of 1 year
To determine the prevalence of prostate cancer (PrCa) specific genetic variation in men with: (a)young onset PrCa; (b) metastatic PrCa; (c) men with PrCa and a family history of PrCa compared with controls.
Secondary Outcomes
- Prostate Cancer genetic variation on clinical outcome(Through study completion, an average of 1 year)
- Prevalence of genetic variation in unaffected men(Through study completion, an average of 1 year)