Creating a reference set for prostate cancer upgrading

Biomarkers and Clinical Parameters Associated With Gleason Score Upgrading

This study is trying to create a tool to help men with low-grade prostate cancer understand their risk of having more aggressive cancer when they undergo surgery.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 35 Years to 99 Years
• Sex: Male
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT02189486 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a prostate cancer upgrading reference set and develop a risk prediction tool for patients diagnosed with low-grade prostate cancer. It will collect clinical information and biological samples from a cohort of 240 men to predict the presence of high-grade cancer at the time of radical prostatectomy. The primary endpoint is to assess tumor upgrading defined as Gleason 3+4 or higher, while secondary endpoints include evaluating the presence of pathologic T3 disease. The study will also involve a central review of pathology slides to confirm eligibility and assess disease characteristics.

Who should consider this trial

Good fit: Ideal candidates are men diagnosed with prostate cancer graded as Gleason 3+3 on biopsy within two years of scheduled radical prostatectomy.

Not a fit: Patients with prostate cancer graded higher than Gleason 3+3 or those not planning to undergo radical prostatectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve risk assessment and treatment decisions for patients with low-grade prostate cancer.

How similar studies have performed: Other studies have shown success in developing risk prediction tools for prostate cancer, indicating that this approach has potential based on prior findings.

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.

Where this trial is running

San Antonio, Texas

• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Ian M Thompson Jr, MD — University of Texas

Conditions: Prostate Cancer, Radical Prostatectomy, Prostate biopsy, Upgrading, Upgrading Reference set