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
Swiss Cancer Institute
OBJECTIVES: * Compare the efficacy and tolerability of exemestane with or without bicalutamide as second-line therapy after failure of androgen suppression (luteinizing hormone-releasing hormone agonist or orchiectomy) in patients with stage IV prostate cancer. * Determine the potential antagonistic effect of the weak androgen action of exemestane when combined with bicalutamide in these patients. * Compare the quality of life (QOL) in patients treated with these regimens. * Correlate prostate-specific antigen response and data of QOL, including scores for pain intensity and analgesic consumption, in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1-2), pain (none or mild vs moderate or severe), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral exemestane once daily. * Arm II: Patients receive exemestane as in arm I and oral bicalutamide once daily. Treatment in both arms continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Quality of life and pain are assessed at baseline, on day 1 of course 2 and any subsequent courses, and at disease progression or treatment failure (if applicable). Patients are followed monthly until disease progression. PROJECTED ACCRUAL: A total of 20-62 patients (10-31 per treatment arm) will be accrued for this study.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
