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.