Open Registry Measuring Impact of Genomic Testing on Treatment Decision After Biopsy in Newly Diagnosed Prostate Cancer Patients
This trial is active, not recruiting.
|Sponsor||Myriad Genetic Laboratories, Inc.|
|Start date||May 2014|
|End date||September 2015|
|Trial size||274 participants|
|Trial identifier||NCT02209584, PROCEDE-2000|
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.
Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).
time frame: 1 months
Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation).
time frame: 1 month
Male participants at least 18 years old.
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
|Official title||An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients by Specialists|
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