Open Registry Measuring Impact of Genomic Testing on Treatment Decision After Biopsy in Newly Diagnosed Prostate Cancer Patients

N/ACompletedNCT02209584

Myriad Genetic Laboratories, Inc.274 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

274

Conditions

Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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