Prostate Active Surveillance Study
Purpose
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.
Condition
- Prostatic Neoplasms
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- University of Washington
Detailed Description
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.