Precision Medicine in the Prostate Cancer Care Pathway

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer, Genetic Predisposition

Intervention / Treatment
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* Genetic: Prostate cancer risk gene panel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Affected cohort: Affected with PrCa < 70 years or Affected with metastatic castration resistant PrCa (mCRPC) at any age or Affected with PrCa and a family history defined as two or more cases in family with one case < 70 three or more cases any age (FDR or SDR) Unaffected cohort: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AFFECTED<br>Affected with PrCa < 70 years Affected with metastatic castration resistant PrCa (mCRPC) at any age Affected with PrCa and a family history defined as two or more cases in family with one case < 70 three or more cases any age (FDR or SDR) | Genetic: Prostate cancer risk gene panel<br>* 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<br>|
| UNAFFECTED<br>- 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) | Genetic: Prostate cancer risk gene panel<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of genetic variation in affected men | 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. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of genetic variation in unaffected men | To determine the prevalence of prostate cancer specific genetic variation in unaffected men with a strong family history of prostate cancer compared with controls. | Through study completion, an average of 1 year | 
| Prostate Cancer genetic variation on clinical outcome | To determine how prostate cancer specific genetic variation influences clinical outcome in 'high-risk' vs 'low risk' groups. | Through study completion, an average of 1 year |