The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.
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.