Overview

This trial is active, not recruiting.

Condition prostate cancer
Sponsor Myriad Genetic Laboratories, Inc.
Start date May 2014
End date September 2015
Trial size 274 participants
Trial identifier NCT02209584, PROCEDE-2000

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Myriad Genetic Laboratories, Inc..