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, 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