PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients
- Conditions
- Prostate Cancer
- Registration Number
- NCT05447637
- Lead Sponsor
- Invitae Corporation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1000
- 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)
- Mental or cognitive impairment that interferes with ability to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic yield of pathogenic and likely pathogenic genes in the patient population to be assessed at baseline only 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.
- Secondary Outcome Measures
Name Time Method Evaluate the impact of genetic test results on clinical management decisions 60-90 days post test results received. 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.
Evaluate the sensitivity of current NCCN criteria for germline genetic testing for identifying prostate cancer patients that have pathogenic/likely pathogenic variants at baseline only Compare rates of pathogenic / likely pathogenic variants found in both cohorts after testing using the Invitae 84 gene multi cancer panel.
Trial Locations
- Locations (19)
Genesis Healthcare Partners
🇺🇸San Diego, California, United States
Invitae
🇺🇸San Francisco, California, United States
Department of Bioengineering and Therapeutic Sciences, University of California San Francisco
🇺🇸San Francisco, California, United States
Volunteer Faculty, University of California San Francisco
🇺🇸San Francisco, California, United States
Colorado Urology
🇺🇸Lakewood, Colorado, United States
Advanced Urology Institute
🇺🇸Saint Petersburg, Florida, United States
Florida Urology Partners
🇺🇸Tampa, Florida, United States
TGH Cancer Institute
🇺🇸Tampa, Florida, United States
North Georgia Urology
🇺🇸Dalton, Georgia, United States
Associated Urological Specialists
🇺🇸Chicago Ridge, Illinois, United States
Scroll for more (9 remaining)Genesis Healthcare Partners🇺🇸San Diego, California, United States