PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Invitae multi-cancer gene panel

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Genesis Healthcare Partners
    • San Francisco, California, United States, 94103
      • Invitae
    • San Francisco, California, United States, 94158
      • Department of Bioengineering and Therapeutic Sciences, University of California San Francisco
    • San Francisco, California, United States, 94158
      • Volunteer Faculty, University of California San Francisco
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Colorado Urology
  • Florida
    • Saint Petersburg, Florida, United States, 33710
      • Advanced Urology Institute
    • Tampa, Florida, United States, 33606
      • Florida Urology Partners
    • Tampa, Florida, United States, 33606
      • TGH Cancer Institute
  • Georgia
    • Dalton, Georgia, United States, 30720
      • North Georgia Urology
  • Illinois
    • Chicago Ridge, Illinois, United States, 60415
      • Associated Urological Specialists
  • New Jersey
    • Hamilton, New Jersey, United States, 08690
      • University Urology Associates of New Jersey
  • New York
    • New York, New York, United States, 10016
      • Perlmutter Cancer Center, NYU Langone Health, New York
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37211
      • Urology Associates, P.C.
  • Texas
    • Arlington, Texas, United States, 76017
      • Urology Partners
    • Austin, Texas, United States, 78759
      • Urology Austin
    • Houston, Texas, United States, 77002
      • Urosurgery Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men who have a diagnosis of prostate cancer who have not previously undergone testing for multi-gene hereditary cancer risk.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals who meet NCCN Testing Criteria	Diagnostic test: Invitae multi-cancer gene panel; Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.
Individuals who do not meet NCCN Testing Criteria	Diagnostic test: Invitae multi-cancer gene panel; Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Invitae Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: INVPC-1000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No