Upgrading Reference Set

Abbreviated Name
Lead Investigator
Leach, Robin JUniversity of Texas Health Science Center at San Antonio
Coordinating Investigator
Feng, Ziding Fred Hutchinson Cancer Center
Involved Investigators


We are proposing a multi-institutional study to identify molecular biomarkers and clinical measures that will predict presence of Gleason 7 or higher cancer (as evidence in the radical prostatectomy specimen) among patients with a biopsy diagnosis of Gleason score ≤ 6 prostate cancer. This proposal will be conducted in two phases. The first phase will assemble an “Upgrading Reference Set” that will include clinical information as well as biologics on a cohort of 600 men. The first phase will also assess the clinical parameters associated with upgrading, as well as, perform a central pathology review of both biopsies and prostatectomy specimens to confirm tumor grade. The second phase will use the biologics collected in phase 1 to evaluate a series of biomarkers to further refine the prediction of Gleason 7-10 cancer at radical prostatectomy.


Aim 1: We will recruit a cohort of 600 men with biopsy Gleason 3+3 prostate cancer who have elected to undergo radical prostatectomy for prostate cancer (see Appendix 1-Model Consent). Preoperative blood and urine samples, prostate biopsy slides, and blocks if available, radical prostatectomy blocks, and slides if available, as well as clinical and demographic data will be collected. Specimen collection will be coordinated by the Data Management and Coordinating Center (DMCC) of the Early Detection Research Network (EDRN). These biologics will be considered the Upgrading Reference Set (URS). Aim 2: Clinical and demographic risk factors related to upgrading and/or biochemical recurrence will be collected and analyzed. Prostate biopsy slides and blocks and radical prostatectomy blocks and slides will be reviewed by the study pathologist, Mark Rubin, MD, Chair of the GU Collaborative Group. Patients will be followed to one intermediate endpoint (tumor grade and stage at radical prostatectomy). Patients will be consented for collection of follow-up data to determine use of adjuvant or salvage treatments (e.g., hormonal or radiotherapy) as well as for monitoring of disease recurrence (e.g., PSA, radiographic imaging studies). They will also be consented for potential long-term contact from either the study sites or the DMCC for collection of these data.

Analytic Method

N/A for repositories, dependent on applicants use of reference set


  • No biomarkers available at this time for this protocol

Data Collections

  • No data available at this time for this protocol
Protocol ID
Protocol Type
Reference Set
Field of Research
Other, Specify
Collaborative Group
Prostate and Urologic Cancers Research Group
Cancer Types
  • Malignant neoplasm of prostate
Phased Status

Associated Forms