Genetic Predisposition, Prostate Cancer
Conditions
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.
Interventions
GENETICProstate cancer risk gene panel
A list of genes created by study experts, thought to increase the risk of prostate cancer from from review previous research, this list is regularly reviewed for accuracy
Sponsors
Royal Marsden NHS Foundation Trust
Institute of Cancer Research, United Kingdom
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Affected cohort: 1. Affected with PrCa \< 60 years or 2. Affected with metastatic castration resistant PrCa (mCRPC) at any age or Aggressive PrCa Gleason 4+4 or higher \<70 years 3. 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: 1. FDR diagnosed \< 70 2. 2 or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed \< 70 years 3. 3 or more cases at any age (on same side of family)
Exclusion criteria
* • WHO performance status 4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of genetic variation in affected men | 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
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of genetic variation in unaffected men | Through study completion, an average of 1 year | To determine the prevalence of prostate cancer specific genetic variation in unaffected men with a strong family history of prostate cancer compared with controls. |
| Prostate Cancer genetic variation on clinical outcome | Through study completion, an average of 1 year | To determine how prostate cancer specific genetic variation influences clinical outcome in 'high-risk' vs 'low risk' groups. |
Countries
United Kingdom
Outcome results
None listed