Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients

N/ACompletedNCT01954004

Myriad Genetic Laboratories, Inc.1,270 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,270

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 (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

Locations (1)

Unnamed facility

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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