Prospective Prolaris Value and Efficacy

NCT ID: NCT03152448

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1511 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2022-03-21

Brief Summary

This is a prospective study 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.

Detailed Description

This is a prospective study 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. Multiple individual VAMC sites will participate in PART 1 of the study. During PART 1 of the study, a three-part questionnaire will be completed to evaluate the PRE-Prolaris test treatment plan, the POST-Prolaris test treatment plan, and the ACTUAL treatment option. Using PRE-Prolaris Test Questionnaire #1 the physician will record the recommendation for first-line therapy based on standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores). The likelihood of recommending a non-interventional therapy approach will also be recorded using a 10-point ordinal scale. 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 and after patient consultation, the physician will complete POST-Prolaris Questionnaire #2 documenting the planned treatment ( interventional treatment or non-interventional). Approximately 6 months from the date of the test results, ACTUAL Treatment Questionnaire #3 will be completed to document the actual treatment administered.

PART 2 of this study is a prospective evaluation of the prognostic utility of Prolaris® testing of prostate biopsy samples obtained from men who participate in PART 1of the study and who undergo radical prostatectomy or radiation therapy or who are managed with WW or AS. The central VAMC site will be responsible for PART 2; individual VAMC sites will not participate in this part of the study. Patients will be followed using medical record review every 6 months for objective progression (BCR, radiographic or radionuclide evidence of metastases or disease specific mortality) through 5 years.

Conditions

Prostate Cancer

Study Design

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

Study Groups

Early Stage Prostate Cancer

Recently diagnosed treatment-naïve patients with early stage localized prostate cancer

Prolaris

Intervention Type: BEHAVIORAL

Series of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result

Interventions

Prolaris

Series of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result

Intervention Type: BEHAVIORAL

Other Intervention Names

RNA expression signature based on a set of cell cycle progression (CCP) genes

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed (<= 6 months), untreated patients with histologically proven adenocarcinoma of the prostate
• Final treatment decision has not been made (that is all treatment options are feasible and none have been ruled out due to comorbidities at study entry)
• Clinically localized (no evidence on clinical or imaging studies of advanced disease)
• No hormonal therapy for treatment of prostate cancer including LHRH agonist or antagonist, anti-androgen, estrogens or exogenous androgens when applicable (use of 5-alpha reductase inhibitors is acceptable)
• Sufficient amount of tissue remains from biopsy to perform genomic testing
• Life expectance of a minimum of 10 years
• Men who completed PART 1 and were treated with radical prostatectomy (including robotic, laparoscopic, open retropubic or perineal) or receive radiation therapy or were placed on AS or WW.

Exclusion Criteria

• Men with clinical node positive or metastatic disease
• Men with a known baseline total serum testosterone level of <100 ng/dL prior to radiation or hormone therapy (men with unknown baseline testosterone levels will not be excluded)
• Men who previously received pelvic radiotherapy for another malignancy
• Non adenocarcinoma prostate cancer histologies

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VA Salt Lake City Health Care System

FED

Sponsor Role: collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VA San Diego Healthcare System

San Diego, California, United States

VA Connecticut Healthcare System

West Haven, Connecticut, United States

James A. Haley Veterans' Hospital

Tampa, Florida, United States

Kansas City VAMC

Kansas City, Kansas, United States

Southeast Louisiana Veterans Healtchare System

New Orleans, Louisiana, United States

Minneapolis VA Healthcare System

Minneapolis, Minnesota, United States

VA St. Louis Healthcare System

St Louis, Missouri, United States

James J. Peters VA

The Bronx, New York, United States

Oklahoma City Veteran's Hospital

Oklahoma City, Oklahoma, United States

Ralph H. Johnson VAMC

Charleston, South Carolina, United States

Michael E. DeBakey VAMC

Houston, Texas, United States

Salt Lake City VA Medical Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

URO-005

Identifier Type: -

Identifier Source: org_study_id