Registry to Measure the Impact of Adding Genomic Testing
Registry to Measure the Impact of Adding Genomic Testing
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.
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, using standard clinical-pathological parameters (PSA,
 Gleason score, clinical stage and percent positive cores), will complete a questionnaire that
 will record their recommendation for first-line therapy from among various treatment options.
 A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a
 relative cancer aggressiveness score will be shared with the physician. After reviewing and
 considering the results of the genomic testing but prior to the patient consult, the
 physician will then complete a second treatment decision questionnaire and VAS again. The
 physician will then discuss the recommended treatment plan with the patient and record the
 agreed treatment plan on a third questionnaire. After the initial treatment has been
 initiated, the physician or research staff will record the actual treatment administered in
 the fourth questionnaire (preferably recorded within 3 months of the patient consultation).
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