A Registry for Hereditary Cancer Risk Assessment and 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 Prostate Cancer in community urology practices nationwide.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Arkansas Urology, Little Rock, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Time frame: 18 weeks per site

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.

Secondary outcomes

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.

Time frame: 18 weeks

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.

Sponsors and collaborators

Lead sponsor

Myriad Genetic Laboratories, Inc.

Industry

Collaborators

Carolina Urologic Research Center

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jul 10, 2019
Registry last updated: Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed