Open Registry Measuring Impact of Genomic Testing on Treatment Decision After Biopsy in Newly Diagnosed Prostate Cancer Patients
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT02209584
- Lead Sponsor
- Myriad Genetic Laboratories, Inc.
- Brief Summary
This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions when added to standard clinical-pathological parameters in men with newly diagnosed prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 274
Inclusion Criteria
- Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
- Clinically localized (no evidence on clinical or imaging studies of advanced disease.
- No hormonal therapy including LHRH agonist or antagonist, anti-androgen, 5-alpha reductase inhibitor, estrogens or exogenous androgens, when applicable.
- Sufficient amount of tissue remains from biopsy to perform genomic testing.
Exclusion Criteria
- Patients with known history of hypogonadism will be excluded from the registry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®). 1 months
- Secondary Outcome Measures
Name Time Method Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation). 1 month
Trial Locations
- Locations (1)
University of Washington
🇺🇸Seattle, Washington, United States
University of Washington🇺🇸Seattle, Washington, United States