An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients at Intermountain Hospitals


Condition: Prostate Cancer

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02454595

Sponsor: Myriad Genetic Laboratories, Inc.

Phase:

Eligibility:

  • Age: minimum 55 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Known history of hypogonadism

View trial on ClinicalTrials.gov