Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT01954004
- Lead Sponsor
- Myriad Genetic Laboratories, Inc.
- Brief Summary
This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1270
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 (luteinizing hormone-releasing hormone) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.
- Sufficient amount of tissue remains from biopsy to perform genomic testing.
Exclusion Criteria
- Patients with a known history of hypogonadism
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 implemented following results of genomic risk assessment testing (Prolaris®). 4 months
- Secondary Outcome Measures
Name Time Method Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following review of the genomic test results (prior to patient consultation) 1 month Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient. 2 months