Status:

COMPLETED

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

Lead Sponsor:

Myriad Genetic Laboratories, Inc.

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Brief 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.

Eligibility Criteria

Inclusion

  • 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

  • Patients with known history of hypogonadism will be excluded from the registry

Key Trial Info

Start Date :

May 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 8 2015

Estimated Enrollment :

274 Patients enrolled

Trial Details

Trial ID

NCT02209584

Start Date

May 1 2014

End Date

December 8 2015

Last Update

September 5 2017

Active Locations (1)

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1

University of Washington

Seattle, Washington, United States, 98195