Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using exemestane plus bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if exemestane is more effective with or without bicalutamide in treating prostate cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of exemestane with or without bicalutamide in treating patients who have stage IV prostate cancer that has been previously treated with hormone therapy or surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer|
|Study Start Date:||August 2001|
|Study Completion Date:||June 2002|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive oral exemestane once daily
Active Comparator: Arm II
Patients receive exemestane as in arm I and oral bicalutamide once daily
Exemestane as in arm I and oral bicalutamide once daily
- 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.
|Aarau, Switzerland, 5001|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Biel, Switzerland, CH-2500|
|Bruderholz, Switzerland, CH-4101|
|Ratisches Kantons und Regionalspital|
|Chur, Switzerland, CH-7000|
|Clinique De Genolier|
|Genolier, Switzerland, Ch-1272|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Istituto Oncologico della Svizzera Italiana|
|Lugano, Switzerland, CH-6900|
|Ospedale Beata Vergine|
|Mendrisio, Switzerland, CH-6850|
|Institut Central des Hopitaux Valaisans|
|Sion, Switzerland, CH1951|
|Zurich, Switzerland, CH-8091|
|Study Chair:||Marco Bonomo, MD||Ospedale Beata Vergine|