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Prostate Active Surveillance Study
Trial ID: NCT00756665
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.
Canary Prostate Active Surveillance Study
- 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
- 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
- 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.