PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447637
• Other study ID #: INVPC-1000
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Invitae Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 31, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Invitae multi-cancer gene panel
Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.

Locations

Country	Name	City	State
United States	Urology Partners	Arlington	Texas
United States	Urology Austin	Austin	Texas
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Associated Urological Specialists	Chicago Ridge	Illinois
United States	North Georgia Urology	Dalton	Georgia
United States	University Urology Associates of New Jersey	Hamilton	New Jersey
United States	Urosurgery Houston	Houston	Texas
United States	Colorado Urology	Lakewood	Colorado
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates, P.C.	Nashville	Tennessee
United States	Perlmutter Cancer Center, NYU Langone Health, New York	New York	New York
United States	Advanced Urology Institute	Saint Petersburg	Florida
United States	Genesis Healthcare Partners	San Diego	California
United States	Department of Bioengineering and Therapeutic Sciences, University of California San Francisco	San Francisco	California
United States	Invitae	San Francisco	California
United States	Volunteer Faculty, University of California San Francisco	San Francisco	California
United States	Associated Medical Professionals	Syracuse	New York
United States	Florida Urology Partners	Tampa	Florida
United States	TGH Cancer Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Invitae Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.