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.

Category

IRB Number
20080303HU
NCT Number
NCT00756665
Open to Enrollment
Yes
Sponsor
University of Washington -



Study Contact

Local Recruitment Point of Contact
Kerri Kendrick
(210) 567-5676
kendrick@uthscsa.edu

Local Recruitment Point of Contact
Carolina Lizcano
210-450-0705
lizcanoc@uthscsa.edu

Local Recruitment Point of Contact
Rafael Sanchez
(210) 567-0115
sanchezr17@uthscsa.edu

Overall Recruitment Point of Contact
Michael Liss
(210) 567-0548
liss@uthscsa.edu

Principal Investigator
Michael Liss

Regulatory Point of Contact
Kerri Kendrick
(210) 567-5676
kendrick@uthscsa.edu

Regulatory Point of Contact
Michael Liss
(210) 567-0548
liss@uthscsa.edu

Regulatory Point of Contact
Rafael Sanchez
(210) 567-0115
sanchezr17@uthscsa.edu



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:

      1. If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
      2. 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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective
Condition
  • Prostatic Neoplasms
  • Arm Groups