Registry to Measure the Impact of Adding Genomic Testing

Stopped early

Conditions studied: Prostate Cancer

In brief

This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.

Key facts

Study ID

NCT02454595

Run by

Myriad Genetic Laboratories, Inc.

People needed

116

Starts

2014-11-01

Expected to finish

2017-07-03

Last updated by the study team

2017-09-05

Who can join

Age: 55 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed (< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics:
• PSA less than or equal to 10 ng/dl and
• Gleason's 7 (4+3 or 3+4) or Gleason's 6 and
• Age greater than 55 years old and
• Clinical Stage T1 or T2
• Clinically localized (no evidence on clinical or imaging studies of advanced disease).
• No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.

You may not qualify if…

• Known history of hypogonadism

Where it is running

• Intermountain Healthcare — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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