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Prostate Cancer Upgrading Reference Set
Recruiting
I'm InterestedTrial ID: NCT02189486
Purpose
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
Keith and Jan Hurlbut Professor
Eligibility
Inclusion Criteria:
1. Prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical
prostatectomy.
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.
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Ferrari
650-725-5543