Exemestane With or Without Bicalutamide in Treating Patients With Stage IV Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Exemestane; Drug: Exemestane+bicalutamide

• Registration Number: NCT00031889
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2002-03-08
• Primary Completion: 2002-06
• Study Completion: 2002-06
• Study First Submitted QC: 2003-06-30
• Study First Posted: 2003-07-01
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm I	Exemestane	Patients receive oral exemestane once daily
Arm II	Exemestane+bicalutamide	Patients receive exemestane as in arm I and oral bicalutamide once daily

Trial Locations

Locations (12)

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Spitalzentrum Biel; 🇨🇭 Biel, Switzerland

Ospedale Beata Vergine; 🇨🇭 Mendrisio, Switzerland

Universitaetsspital; 🇨🇭 Zurich, Switzerland

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

University Hospital; 🇨🇭 Basel, Switzerland

Kantonsspital Bruderholz; 🇨🇭 Bruderholz, Switzerland

Ratisches Kantons und Regionalspital; 🇨🇭 Chur, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Clinique De Genolier; 🇨🇭 Genolier, Switzerland

Institut Central des Hopitaux Valaisans; 🇨🇭 Sion, Switzerland

Istituto Oncologico della Svizzera Italiana; 🇨🇭 Lugano, Switzerland