Prostate Active Surveillance Study

Recruiting

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00756665
• Lead Sponsor: University of Washington

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 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.

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.

* To measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-12
• Primary Completion: 2029-09
• Study Completion: 2032-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 3000

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

Stanford University; 🇺🇸 Stanford, California, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Veterans Affairs San Francisco Health Care System; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center/Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States

University of Texas Health Science Center, San Antonio; 🇺🇸 San Antonio, Texas, United States

Veterans Affairs Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States

University of Washington; 🇺🇸 Seattle, Washington, United States