Prostate Cancer Upgrading Reference Set

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.