NCT04015102

A Registry for Hereditary Cancer Risk Assessment and Genetic Testing

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 255 (actual)
• Sponsor: Myriad Genetic Laboratories, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Timeline

• Start date: 2019-03-06
• Primary completion: 2020-10-21
• Completion: 2020-10-30
• First posted: 2019-07-10
• Last updated: 2020-11-05

Locations

10 sites across 1 country: United States