Prostate Active Surveillance Study
Canary Prostate Active Surveillance Study
About This Trial
- This study is for men with early-stage prostate cancer who have chosen to monitor their condition closely instead of having immediate treatment.
- Researchers are looking for biological signs that can help doctors predict whether a cancer will remain slow-growing or become more aggressive.
- To be eligible, you must have been diagnosed within the past three years and have had no prior prostate cancer treatments like surgery or radiation.
- Before joining, you should know that participation requires attending regular follow-up visits and undergoing scheduled repeat prostate biopsies over time.
More Information
- 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.
Who Can Enroll
- Age Range: 21 years and older
- Gender: Male
- Who This Trial is For: This study is for men with early-stage prostate cancer who have chosen to monitor their condition closely instead of having immediate treatment.
Study Details
- Start Date: July 2008
- Lead Sponsor: University of Washington
Full Eligibility Criteria
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.