A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
- Compare the effect of neoadjuvant exisulind vs no neoadjuvant treatment on apoptosis in
patients with stage II or III prostate cancer undergoing radical prostatectomy.
- Determine the effect of this drug (preoperatively) on surrogate endpoint biomarkers
(i.e., prostate-specific antigen, high-grade prostatic intraepithelial neoplasia,
MIB-1, and DNA ploidy) in these patients.
OUTLINE: This is a nonrandomized, controlled study. Patients are assigned to 1 of 2 groups
based on the treating physician.
- Control group: Patients undergo radical prostatectomy only.
- Treatment group: Patients receive oral exisulind once daily for 4 weeks. Patients then
undergo radical prostatectomy.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 130 patients (65 per group) will be accrued for this study
within approximately 10-12 months.
Allocation: Non-Randomized, Primary Purpose: Treatment
Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)
Bradley C. Leibovich, MD
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|