Prostate Active Surveillance Study

This is a multi-center, prospective active surveillance study with selective intervention in
patients with previously untreated, clinically localized prostate cancer at diagnosis.
Candidates are assessed based on an extended core biopsy, serum PSA (including PSA kinetics,
if available), digital rectal examination (DRE), and assessment of cancer grade and extent.

Active surveillance is defined as serial PSA measurements and prostate examination with
routine prostate biopsy and therapeutic intervention considered at the time one or more of
the following:

- Grade or volume progression

- Clinical progression

The objectives of the study are as follows:

Primary Objective

• To discover and confirm biomarkers that predict aggressive disease as defined by
pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.

Secondary Objectives

- To determine the proportion of patients on active surveillance who progress based on the
above criteria.

- To determine the clinical predictors of disease progression.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate.

- Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.

- No previous treatment for prostate cancer (including hormonal therapy, radiation
therapy, surgery, or chemotherapy).

- ECOG Performance Status 0 or 1.

- Patient has elected Active Surveillance as preferred management plan for prostate
cancer.

- Patient consent has been obtained according to local Institutional Review Board for
acquisition of research specimens.

- Patient is accessible and compliant for follow-up.

- Prostate biopsy requirements:

1. If diagnosis was within one year of baseline visit, participant must have at
least one biopsy with at least 10 cores.

2. If diagnosis was more than 1 year prior to baseline visit, participant must have
a minimum of 2 biopsies, one of which must be within 2 years prior to baseline
visit.

Exclusion Criteria:

- Unwillingness or inability to undergo serial prostate biopsy.

- History of other malignancies, except: adequately treated non-melanoma skin cancer or
adequately treated superficial bladder cancer (Ta) or other solid tumors curatively
treated with no evidence of disease for > 5 years.