Clinical trial NCT05447637: PROCLAIM: Germline Genetic Testing for Prostate Cancer Patients
Official title: A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Invitae Corporation
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield of pathogenic and likely pathogenic genes in the patient population
timeFrame: to be assessed at baseline only
Secondary outcomes:
measure: Evaluate the sensitivity of current NCCN criteria for germline genetic testing for identifying prostate cancer patients that have pathogenic/likely pathogenic variants
timeFrame: at baseline only
measure: Evaluate the impact of genetic test results on clinical management decisions
timeFrame: 60-90 days post test results received.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Genesis Healthcare Partners
state: California
city: San Francisco
country: United States
facility: Invitae
state: California
city: San Francisco
country: United States
facility: Department of Bioengineering and Therapeutic Sciences, University of California San Francisco
state: California
city: San Francisco
country: United States
facility: Volunteer Faculty, University of California San Francisco
state: California
city: Lakewood
country: United States
facility: Colorado Urology
state: Colorado
city: Saint Petersburg
country: United States
facility: Advanced Urology Institute
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Tampa
country: United States
facility: TGH Cancer Institute
state: Florida
city: Dalton
country: United States
facility: North Georgia Urology
state: Georgia
city: Chicago Ridge
country: United States
facility: Associated Urological Specialists
state: Illinois
city: Hamilton
country: United States
facility: University Urology Associates of New Jersey
state: New Jersey
city: New York
country: United States
facility: Perlmutter Cancer Center, NYU Langone Health, New York
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: Arlington
country: United States
facility: Urology Partners
state: Texas
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Houston
country: United States
facility: Urosurgery Houston
state: Texas
Study officials:
References: