Clinical trial NCT04015102: A Registry for Hereditary Cancer Risk Assessment and Genetic Testing
Official title: A Registry for Hereditary Cancer Risk Assessment and Genetic Testing Among Men With Prostate Cancer in the Community Urology Practice Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer Patients
myRisk genetic testing
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Carolina Urologic Research Center
First posted: 2019-07-10
Enrollment: 255
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate Cancer patients, at least 18 years or older, who meet NCCN guidelines and eligibility criteria, who have a scheduled set appointment at Community Urology practices.

Brief summary: This prospective registry will evaluate the feasibility and impact of implementing standard cancer family history review and guideline-aligned genetic testing for men diagnosed with Prostate Cancer in community urology practices nationwide.

Detailed description: Genes linked to hereditary cancer syndromes have been associated with increased risk for prostate cancer (PrCa), earlier disease onset and increased disease aggressiveness.1,2 Ascertaining family cancer history and hereditary risk in men diagnosed with PrCa can help inform medical management decisions. Recently published National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Prostate Cancer (v3.2018)3 and Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019)4 as well as the American Urological Association Guideline for Clinically Localized Prostate Cancer (2017)5 recommend appropriate counseling and genetic testing for men who are at increased hereditary cancer risk, based upon personal or family history. Genetic testing for patients with metastatic prostate cancer is now standard of care per NCCN Genetic/Familial High Risk Assessment: Breast and Ovarian (v2.2019) guidelines4. NCCN Prostate Cancer Guidelines (v3.2018)3 recommend obtaining a cancer-focused family history at diagnosis and consideration of germline genetic testing in multiple risk groups. Community urology practices can support guideline-aligned care by performing routine hereditary cancer risk assessment (HCRA), patient counseling and, when appropriate, genetic testing. This prospective registry will evaluate the feasibility and impact of implementing standard cancer family history review and guideline-aligned genetic testing for men diagnosed with PrCa in community urology practices nationwide.

Eligibility criteria: Inclusion Criteria:

* 18 Years of age or older at time of enrollment
* Affected with Prostate Cancer (newly or previously diagnosed patients).
* Presents for a medical care visit and meets eligibility criteria for hereditary cancer genetic testing, based on personal and family cancer history and NCCN Practice Guidelines in Oncology (Prostate Cancer)
* Able to understand informed consent and agrees to participate in the registry.

Exclusion Criteria:

* Minors (younger than 18 years of age)
* Have had previous genetic testing for Hereditary Breast and Ovarian Cancer or Lynch Syndrome, or have previously undergone hereditary multi-gene, pan-cancer, or panel testing.
* Unable to provide routine clinical informed consent.

Primary outcomes:
measure: To see how practical it would be to integrate a standard hereditary cancer risk assessment, patient counseling and genetic testing process into the community urology practice setting.
timeFrame: 18 weeks per site
Secondary outcomes:
measure: To see what the proportion of community urology patients with PrCa is who complete each component of the HCRA, patient counseling and genetic testing process.
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: Merrillville
country: United States
facility: Urologic Specialists of Northwest Indiana
state: Indiana
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Waterford
country: United States
facility: Comprehensive Urology
state: Michigan
city: Syracuse
country: United States
facility: Associated Medical Professionals of New York
state: New York
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
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
Study officials:
affiliation: Carolina Urologic Research Center
name: Neal Shore, MD
role: PRINCIPAL_INVESTIGATOR
References: