Status:
RECRUITING
Prostate Active Surveillance Study
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Canary Foundation
Early Detection Research Network
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
21+ years
Brief Summary
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 mo...
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 asses...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2032
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00756665
Start Date
July 1 2008
End Date
September 1 2032
Last Update
July 24 2025
Active Locations (11)
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1
Veterans Affairs San Francisco Health Care System
San Francisco, California, United States, 94121
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305
4
Emory University
Atlanta, Georgia, United States, 30322