Prostate Active Surveillance Study

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Veterans Affairs San Francisco Health Care System, San Francisco, California, United States
• University of California, San Francisco, San Francisco, California, United States
• Stanford University, Stanford, California, United States
• Emory University, Atlanta, Georgia, United States
• Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts, United States
• University of Michigan, Ann Arbor, Michigan, United States
• University of Texas Health Science Center, San Antonio, San Antonio, Texas, United States
• Eastern Virginia Medical School, Norfolk, Virginia, United States
• Veterans Affairs Puget Sound Health Care System, Seattle, Washington, United States
• University of Washington, Seattle, Washington, United States
• University of British Columbia, Vancouver, British Columbia, Canada

Who to contact

Lisa Newcomb, PhD · lnewcomb@fredhutch.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT00756665.