Registry to Measure the Impact of Adding Genomic Testing

NCT ID: NCT02454595

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-07-03

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Prolaris

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed (< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics:
• PSA less than or equal to 10 ng/dl and
• Gleason's 7 (4+3 or 3+4) or Gleason's 6 and
• Age greater than 55 years old and
• Clinical Stage T1 or T2
• Clinically localized (no evidence on clinical or imaging studies of advanced disease).
• No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.

Exclusion Criteria

• Known history of hypogonadism

• Minimum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Intermountain Health Care, Inc.

OTHER

Sponsor Role: collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Wenstrup, MD

Role: STUDY_DIRECTOR

Myriad Genetic Laboratories, Inc.

Locations

Intermountain Healthcare

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

URO-006

Identifier Type: -

Identifier Source: org_study_id