Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer

This is a long-term prospective registry to evaluate the impact of Prolaris testing on
therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized
prostate cancer and to summarize clinical oncologic outcomes. The design of the study is
non-interventional, and therefore the protocol will not require a specific treatment plan for
study participants. However, in the absence of a universally accepted timeframe for repeat
biopsies within existing active surveillance recommendations, study sites will be encouraged
to monitor patients for disease progression as per the standard of care (e.g., current
National Comprehensive Cancer Network [NCCN] guidelines) with the expectation of a repeat
biopsy within 18 months of the initial biopsy.

Patients who undergo Prolaris testing will be included in the registry as well as patients
who do not undergo Prolaris testing. Data collection for the first primary objective extends
over a 3-year period. During this time, data is collected on the treatment initiated, any
follow-up prostate biopsy performed in patients initially treated with active surveillance,
definitive treatments performed (with pathology data if surgical therapy is performed), and
the reasons definitive treatment was pursued, as well as data related to disease progression
such as biochemical recurrence, development of prostate cancer metastases, or disease
specific death.

Data collection for the second primary objective extends out to 8 years. During this time
data is collected on any follow-up prostate biopsy in patients still treated with active
surveillance, definitive treatments performed (with pathology data if surgical therapy is
performed), and the reasons definitive treatment was pursued, as well as data related to
disease progression such as biochemical recurrence, development of prostate cancer
metastases, or disease specific death.

Inclusion Criteria:

- Patients who have undergone CCP testing and patients who have not undergone CCP
testing will be considered for enrollment in the study.

1. Willing to provide written informed consent.

2. Males ≥65 years old.

3. Newly diagnosed (≤6 months), treatment-naïve patient with histologically proven
localized adenocarcinoma of prostate whose initial treatment has not been
decided.

4. Candidate for and considering AS and yet would be eligible for definitive
therapy.

5. Favorable intermediate-risk disease, defined by the NCCN as follows:

- predominant Gleason grade 3; AND

- percentage of positive cores <50%; AND

- no more than 1 of the following NCCN intermediate-risk factors:

- Gleason grade 7

- T2b-T2c

- PSA 10-20 ng/mL

6. Estimated life expectancy ≥10 years.

7. Can be monitored for disease progression according to standard of care (e.g.,
current NCCN guidelines).

Exclusion Criteria:

- 1. Clinical evidence of metastasis or lymph node involvement.

- 2. Received pelvic radiation prior to biopsy.

- 3. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5
alpha-reductase inhibitors (5-ARIs) are permitted.

- 4. Participation in interventional clinical trials.

- 5. Patient is considering watchful waiting.

- 6. Has a known history of hypogonadism.