Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

University of Texas Health Science Center, San Antonio
San Antonio, Texas 78229
Contact:
Azaneth Arellanes
210-573-7034
arellanes@uthscsa.edu

More Details

NCT ID
NCT00756665
Status
Recruiting
Sponsor
University of Washington

Study Contact

Lisa Newcomb, PhD
lnewcomb@fredhutch.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.