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)
1 other identifier
observational
1,000
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedFirst Submitted
Initial submission to the registry
July 1, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedJuly 7, 2022
July 1, 2022
1.7 years
July 1, 2022
July 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Evaluate the impact of genetic test results on clinical management decisions
60-90 days post test results received.
Study Arms (2)
Individuals who meet NCCN Testing Criteria
Individuals who do not meet NCCN Testing Criteria
Interventions
Invitae's multi-cancer panel tests for 84 genes associated with hereditary cancer risk.
Eligibility Criteria
Men who have a diagnosis of prostate cancer who have not previously undergone testing for multi-gene hereditary cancer risk.
You may qualify if:
- 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)
You may not qualify if:
- Mental or cognitive impairment that interferes with ability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Genesis Healthcare Partners
San Diego, California, 92123, United States
Invitae
San Francisco, California, 94103, United States
Department of Bioengineering and Therapeutic Sciences, University of California San Francisco
San Francisco, California, 94158, United States
Volunteer Faculty, University of California San Francisco
San Francisco, California, 94158, United States
Colorado Urology
Lakewood, Colorado, 80228, United States
Advanced Urology Institute
St. Petersburg, Florida, 33710, United States
Florida Urology Partners
Tampa, Florida, 33606, United States
TGH Cancer Institute
Tampa, Florida, 33606, United States
North Georgia Urology
Dalton, Georgia, 30720, United States
Associated Urological Specialists
Chicago Ridge, Illinois, 60415, United States
University Urology Associates of New Jersey
Hamilton, New Jersey, 08690, United States
Perlmutter Cancer Center, NYU Langone Health, New York
New York, New York, 10016, United States
Associated Medical Professionals
Syracuse, New York, 13210, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates, P.C.
Nashville, Tennessee, 37211, United States
Urology Partners
Arlington, Texas, 76017, United States
Urology Austin
Austin, Texas, 78759, United States
Urosurgery Houston
Houston, Texas, 77002, United States
Biospecimen
Blood samples provided for clinical genetic testing that include DNA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2022
First Posted
July 7, 2022
Study Start
November 1, 2019
Primary Completion
July 1, 2021
Study Completion
May 31, 2022
Last Updated
July 7, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share
No plan to share IPD at this time.