Prostate Cancer Upgrading Reference Set

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Jul 10, 2014

Keywords

ClinConnect Summary

The Prostate Cancer Upgrading Reference Set trial is studying men with low-grade prostate cancer to help doctors predict if they might have higher-grade cancer when they undergo prostate surgery. The researchers are collecting clinical information and biological samples from 240 men who have been diagnosed with a specific type of prostate cancer (Gleason score 3+3) within two years of their scheduled surgery. This information will be used to develop a tool that can help assess the risk of having more aggressive cancer at the time of surgery.

To participate in this trial, men must have a confirmed diagnosis of prostate cancer from a biopsy and plan to have surgery to remove the prostate. They need to provide samples of blood and urine, as well as information about their health and family history related to prostate cancer. The trial is currently recruiting participants, and those who join can expect to help advance research that may improve future treatment and care for prostate cancer patients.

Gender

MALE

Eligibility criteria

• 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.