Summary

Eligibility
for males ages 21 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Peter R. Carroll, MD, MPHMatthew R. Cooperberg, MD, MPH
Headshot of Peter R. Carroll
Peter R. Carroll
Headshot of Matthew R. Cooperberg
Matthew R. Cooperberg

Description

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.

Official Title

Canary Prostate Active Surveillance Study

Details

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.

Keywords

Prostatic Neoplasms, prostate, cancer

Eligibility

You can join if…

Open to males ages 21 years and up

  • 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 CAN'T 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.

Locations

  • Veterans Affairs San Francisco Health Care System accepting new patients
    San Francisco California 94121 United States
  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Lead Scientists at UCSF

  • Peter R. Carroll, MD, MPH
    My research interests include identifying clinical and pathologic determinants of prostate cancer detection, recurrence, progression, and mortality; discovering novel biomarkers for prostate cancer diagnostics and prognostics, developing evidence-based guidelines for improved management of prostate cancer including surveillance alone, refining the use and outcomes of robotic s…
  • Matthew R. Cooperberg, MD, MPH
    Both clinician and patient decisions influence the choices about the type of treatment a patient will receive for localized prostate and kidney (renal) cancer. Matthew Cooperberg, MD, MPH is conducting an ongoing research program to study national prostate cancer management trends, based on data from CaPSURE and other sources.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Washington
ID
NCT00756665
Study Type
Observational
Participants
Expecting 3000 study participants
Last Updated