A Registry for Hereditary Cancer Risk Assessment and Genetic Testing

Prostate Cancer Clinical Trial

Official title:

A Registry for Hereditary Cancer Risk Assessment and Genetic Testing Among Men With Prostate Cancer in the Community Urology Practice Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015102
• Other study ID #: URO-012
• Status: Completed
• Start date: March 6, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: October 30, 2020
• Est. primary completion date: October 21, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Urology Associates of Central California	Fresno	California
United States	Arkansas Urology	Little Rock	Arkansas
United States	Urologic Specialists of Northwest Indiana	Merrillville	Indiana
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Comprehensive Urology	Royal Oak	Michigan
United States	Oregon Urology Institute	Springfield	Oregon
United States	Associated Medical Professionals of New York	Syracuse	New York
United States	Comprehensive Urology	Waterford	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.	Carolina Urologic Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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. Also to evaluate the impact of the integrated process on provider and patient satisfaction. This registry will gather information to evaluate the feasibility of HCRA and genetic testing process integration in the Urology community practice setting. Analysis of the registry will compare historical pre-process integration data with post-integration data from the same providers within participating community Urology practices.	18 weeks per site
Secondary	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.	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. This registry will gather information to evaluate the feasibility of HCRA and genetic testing process integration in the Urology community practice setting. Analysis of the registry will compare historical pre-process integration data with post-integration data from the same providers within participating community Urology practices.	18 weeks