Lay Description

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.


  • Mens Health
IRB Number
NCT Number
Open to Enrollment


Eligible Ages
Over 21 Years
Eligible Genders
Accepts Healthy Volunteers

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

Arm Groups

Study Contact

Molly Doris
(210) 562-6541

Kerri Kendrick
(210) 567-5676

Michael Liss
(210) 567-0548

Rafael Sanchez
(210) 567-0115

Brandi Weaver
(210) 567-0158

Kerri Kendrick
(210) 567-5676

Carolina Lizcano

Rafael Sanchez
(210) 567-0115

Michael Liss
(210) 567-0548

Principal Investigator
Michael Liss