A Randomized, Placebo-Controlled Phase IIb Clinical Trial of 2-Difluoromethylornithine (DFMO) Versus Bicalutamide (CASODEX) Alone and in Combination in Patients With Prostate Cancer in the Period Prior to Radical Prostatectomy or Brachytherapy: Modulation of Tissue and Molecular Biomarkers in Human Prostate Tissue Serum
- Compare levels of polyamine spermine, polyamine putrescine, and spermidine in patients
with localized prostate cancer undergoing brachytherapy or radical prostatectomy and
treated with neoadjuvant eflornithine and bicalutamide vs eflornithine alone vs
bicalutamide alone vs no neoadjuvant therapy.
- Compare the expression of surrogate biomarkers (i.e., serum prostate-specific antigen,
tissue levels of proliferating cell nuclear antigen, Ki67, and TGF-alpha, apoptosis
assays [ICH-PARP and TUNEL], and cytomorphometric indices) in patients treated with
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to Gleason score (< 7 vs ≥ 7). Patients are randomized to 1 of 4
- Arm I: Patients receive oral eflornithine and oral bicalutamide once daily.
- Arm II: Patients receive oral eflornithine and oral bicalutamide placebo once daily.
- Arm III: Patients receive oral eflornithine placebo and oral bicalutamide once daily.
- Arm IV: Patients receive oral eflornithine placebo and oral bicalutamide placebo once
In all arms, treatment continues for 28 days in the absence of unacceptable toxicity.
Patients then undergo either prostatectomy or brachytherapy, as determined by the patient,
on day 29.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 44 patients (11 per treatment arm) will be accrued for this
study within 11 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Donald A. Urban, MD
University of Alabama at Birmingham
United States: Federal Government
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|