PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

Invitae

Status

Completed

Conditions

Prostate Cancer

Treatments

Diagnostic Test: Invitae multi-cancer gene panel

Study type

Observational

Funder types

Industry

Identifiers

NCT05447637

INVPC-1000

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,000 patients

Sex

Male

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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