Prospective Prolaris Value and Efficacy
- Conditions
- Prostate Cancer
- Interventions
- Behavioral: Prolaris
- Registration Number
- NCT03152448
- Lead Sponsor
- Myriad Genetic Laboratories, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 1511
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Early Stage Prostate Cancer Prolaris Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
- Primary Outcome Measures
Name Time Method Impact of Prolaris on the magnitude of change between Pre-Prolaris treatment selection and the actual implemented treatment 6 months Comparison of percentage change from the Pre-Prolaris test treatment option (based on standard clinical pathological parameters) versus the actual treatment option implemented following results of Prolaris
Prolaris prediction of biochemical or objective recurrence 5 years Biochemical recurrence (defined as PSA \>0.2 ng/ml or by Phoenix definition) or objective recurrences of disease by 5 years following definitive therapy with curative intent in men treatment with radical prostatectomy or radiation therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
VA Connecticut Healthcare System
🇺🇸West Haven, Connecticut, United States
Kansas City VAMC
🇺🇸Kansas City, Kansas, United States
James A. Haley Veterans' Hospital
🇺🇸Tampa, Florida, United States
Minneapolis VA Healthcare System
🇺🇸Minneapolis, Minnesota, United States
James J. Peters VA
🇺🇸Bronx, New York, United States
Southeast Louisiana Veterans Healtchare System
🇺🇸New Orleans, Louisiana, United States
VA St. Louis Healthcare System
🇺🇸Saint Louis, Missouri, United States
Oklahoma City Veteran's Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Ralph H. Johnson VAMC
🇺🇸Charleston, South Carolina, United States
Salt Lake City VA Medical Center
🇺🇸Salt Lake City, Utah, United States
Michael E. DeBakey VAMC
🇺🇸Houston, Texas, United States