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Summary

for males ages 21 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

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.

Keywords

Prostatic Neoplasms prostate cancer

Eligibility

You can join if…

Open to males ages 21 years and up

  • 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 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 biopsy requirements:
  • If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
  • 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 visit.

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

  • University of California, San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • Stanford University accepting new patients
    Stanford, California, 94305, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Washington
ID
NCT00756665
Lead Scientist
Peter R. Carroll
Study Type
Observational
Last Updated
November 7, 2017
I’m interested in this study!