Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Alabama at Birmingham
With
OBJECTIVES: * 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 these regimens. * 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 treatment arms. * 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 daily. 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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted