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PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients

Sponsor
Invitae Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT05447637
Collaborator
(none)
1,000
Enrollment
19
Locations
30.9
Actual Duration (Months)
52.6
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
May 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Genesis Healthcare Partners San Diego California United States 92123
2 Invitae San Francisco California United States 94103
3 Department of Bioengineering and Therapeutic Sciences, University of California San Francisco San Francisco California United States 94158
4 Volunteer Faculty, University of California San Francisco San Francisco California United States 94158
5 Colorado Urology Lakewood Colorado United States 80228
6 Advanced Urology Institute Saint Petersburg Florida United States 33710
7 Florida Urology Partners Tampa Florida United States 33606
8 TGH Cancer Institute Tampa Florida United States 33606
9 North Georgia Urology Dalton Georgia United States 30720
10 Associated Urological Specialists Chicago Ridge Illinois United States 60415
11 University Urology Associates of New Jersey Hamilton New Jersey United States 08690
12 Perlmutter Cancer Center, NYU Langone Health, New York New York New York United States 10016
13 Associated Medical Professionals Syracuse New York United States 13210
14 MidLantic Urology Bala-Cynwyd Pennsylvania United States 19004
15 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
16 Urology Associates, P.C. Nashville Tennessee United States 37211
17 Urology Partners Arlington Texas United States 76017
18 Urology Austin Austin Texas United States 78759
19 Urosurgery Houston Houston Texas United States 77002

Sponsors and Collaborators

  • Invitae Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Invitae Corporation
ClinicalTrials.gov Identifier:
NCT05447637
Other Study ID Numbers:
  • INVPC-1000
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 7, 2022