PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

Invitae Corporation1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Prostate Cancer

Interventions

Invitae multi-cancer gene panelDIAGNOSTIC_TEST

Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (19)

Genesis Healthcare Partners

San Diego, California, United States

Invitae

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: to be assessed at baseline only

Secondary Outcomes

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.

Time frame: 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.

Time frame: 60-90 days post test results received.

Data from ClinicalTrials.gov

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