A Randomized Phase II Trial of Exemestane With and Without Bicalutamide as Second Line Therapy After Failure of Androgen Suppression in Advanced Prostate Cancer
- 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
- 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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Marco Bonomo, MD
Ospedale Beata Vergine