PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients
July 1, 2022 updated by: Invitae Corporation
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92123
- Genesis Healthcare Partners
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San Francisco, California, United States, 94103
- Invitae
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San Francisco, California, United States, 94158
- Department of Bioengineering and Therapeutic Sciences, University of California San Francisco
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San Francisco, California, United States, 94158
- Volunteer Faculty, University of California San Francisco
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Colorado
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Lakewood, Colorado, United States, 80228
- Colorado Urology
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Florida
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Saint Petersburg, Florida, United States, 33710
- Advanced Urology Institute
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Tampa, Florida, United States, 33606
- Florida Urology Partners
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Tampa, Florida, United States, 33606
- TGH Cancer Institute
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Georgia
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Dalton, Georgia, United States, 30720
- North Georgia Urology
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Illinois
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Chicago Ridge, Illinois, United States, 60415
- Associated Urological Specialists
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New Jersey
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Hamilton, New Jersey, United States, 08690
- University Urology Associates of New Jersey
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New York
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New York, New York, United States, 10016
- Perlmutter Cancer Center, NYU Langone Health, New York
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Syracuse, New York, United States, 13210
- Associated Medical Professionals
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, United States, 19004
- MidLantic Urology
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, United States, 37211
- Urology Associates, P.C.
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Texas
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Arlington, Texas, United States, 76017
- Urology Partners
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Austin, Texas, United States, 78759
- Urology Austin
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Houston, Texas, United States, 77002
- Urosurgery Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Individuals who meet NCCN Testing Criteria
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Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.
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Individuals who do not meet NCCN Testing Criteria
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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
Time Frame: 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.
|
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
Time Frame: at baseline only
|
Compare rates of pathogenic / likely pathogenic variants found in both cohorts after testing using the Invitae 84 gene multi cancer panel.
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at baseline only
|
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Evaluate the impact of genetic test results on clinical management decisions
Time Frame: 60-90 days post test results received.
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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.
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60-90 days post test results received.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.