NCT02454595

Registry to Measure the Impact of Adding Genomic Testing

An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients at Intermountain Hospitals

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Myriad Genetic Laboratories, Inc. · Industry
• Sex: Male
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.

Detailed description

This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer . Physicians, using standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores), will complete a questionnaire that will record their recommendation for first-line therapy from among various treatment options. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing but prior to the patient consult, the physician will then complete a second treatment decision questionnaire and VAS again. The physician will then discuss the recommended treatment plan with the patient and record the agreed treatment plan on a third questionnaire. After the initial treatment has been initiated, the physician or research staff will record the actual treatment administered in the fourth questionnaire (preferably recorded within 3 months of the patient consultation).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Registry	Physician will complete a series of four questionnaires to capture the treatment decisions based upon standard clinical-pathological information and with the addition of the result of genomic testing (Prolaris test).

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-07-03
• Completion: 2017-07-03
• First posted: 2015-05-27
• Last updated: 2017-09-05

Locations

1 site across 1 country: United States