PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

Study Overview
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Brief Summary
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This registry is for men who have prostate cancer and have had multigene panel hereditary testing. The registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. It will also gather data on the patient's experience with genetic testing, through a post-test survey to be completed 60-90days after results have been received and discussed with their provider.

Detailed Description
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This registry will enroll men with prostate cancer who have done multi-gene testing for their cancer. Patients will be enrolled into two cohorts, one for individuals who meet current NCCN testing guidelines, and one for individuals who do not meet current NCCN guidelines. The main goal of this Registry is to assess whether nationally developed guidelines used to select patients for hereditary testing are adequate to identify all patients with prostate cancer who may benefit from testing. Patients will completed a post-test survey regarding their testing experience and clinicians will be asked to provide additional medical records review information via the Clinician Report Form.

Official Title
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A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Invitae multi-cancer gene panel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men ages 18-90 who have been prescribed genetic testing as part of their clinical care Have prostate cancer at any stage, either actively under treatment or being followed who either: 1. meet NCCN criteria for testing or 2. do not meet NCCN criteria for testing Patients who are naive to clinical genetic testing for BRCA1/BRCA2 (single gene panel testing) Exclusion Criteria: Mental or cognitive impairment that interferes with ability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Individuals who meet NCCN Testing Criteria<br> | Diagnostic Test: Invitae multi-cancer gene panel<br>* Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.<br>|
| Individuals who do not meet NCCN Testing Criteria<br> | Diagnostic Test: Invitae multi-cancer gene panel<br>* Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of pathogenic and likely pathogenic genes in the patient population | Identify the diagnostic yield of pathogenic/likely pathogenic variants in known cancer syndrome genes in patients with prostate cancer, using the Invitae 84 gene multi-cancer panel. These rates will be compared between the two cohorts. | to be assessed at baseline only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the sensitivity of current NCCN criteria for germline genetic testing for identifying prostate cancer patients that have pathogenic/likely pathogenic variants | Compare rates of pathogenic / likely pathogenic variants found in both cohorts after testing using the Invitae 84 gene multi cancer panel. | at baseline only | 
| Evaluate the impact of genetic test results on clinical management decisions | Post-Test surveys for patients and the clinician report form will assess whether changes to clinical management were made as a result of the test results. | 60-90 days post test results received. |