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.
• To measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

Inclusion criteria

• Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy.
• 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 cancer diagnosis cannot be more than 3 years prior to baseline visit date.
• No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed.
• If cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. The subsequent biopsy may occur on the same day as the baseline visit.
• Biopsies must have at least 10 cores.

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.