Prostate Cancer Upgrading Reference Set


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Trial ID: NCT02189486


Research repository designed to establish prostate cancer upgrading reference set and development of a risk prediction tool. Repository will include clinical information and biologics on a cohort of 240 men, to predict presence of high grade cancer at time of prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time of biopsy.

Official Title

Biomarkers and Clinical Parameters Associated With Gleason Score Upgrading

Stanford Investigator(s)

James D. Brooks
James D. Brooks

Keith and Jan Hurlbut Professor


Inclusion Criteria:

   1. Prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical

   2. Prostate cancer must be graded as Gleason 3+3 on the biopsy immediately prior to
   radical prostatectomy. (Secondary eligibility will be established on central review of
   pathology slides, and blocks if available, at Cornell Central Pathology Laboratory to
   confirm eligibility.)

   3. Prostate cancer may have been detected on prior biopsy as well but must not be greater
   than Gleason 3+3. (Also requires Central Pathology Laboratory review.)

   4. Slides must be available for Central Pathology Laboratory review on any biopsy showing
   prostate cancer. FFPE Blocks may also be requested if available.

   5. Patient must have selected radical prostatectomy as treatment for prostate cancer.

   6. Signed informed consent.

   7. Blocks and/or slides from prostate biopsy and from radical prostatectomy must be
   available for analysis by Central Pathology laboratory.

   8. Willingness to provide long-term follow-up information regarding additional treatments
   and cancer status.

   9. Willingness to provide blood and urine specimens prior to radical prostatectomy for
   placement in the EDRN Upgrading Reference Set repository.

10. Willingness to provide demographic and clinical information related to prostate cancer
   and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).

Exclusion Criteria:

   1. Gleason score greater than 3+3 on any prior prostate biopsy.

   2. Any treatment other than radical prostatectomy planned for prostate cancer.

   3. Prior treatment of the prostate with androgen deprivation, radiation, or other
   cytotoxic chemotherapy.


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michelle Ferrari

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