Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients
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Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®). [ Time Frame: 4 months ]
Secondary Outcome Measures :
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) [ Time Frame: 1 month ]
Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient. [ Time Frame: 2 months ]
Other Outcome Measures:
• The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing. [ Time Frame: 4 months ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Recently diagnosed treatment-naïve patients with early stage localized prostate cancer
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.