Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over		SWS-SAKK-09/01 EU-20139, NCT00031889

Objectives

1. 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.
2. Determine the potential antagonistic effect of the weak androgen action of exemestane when combined with bicalutamide in these patients.
3. Compare the quality of life (QOL) in patients treated with these regimens.
4. Correlate prostate-specific antigen response and data of QOL, including scores for pain intensity and analgesic consumption, in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed stage IV adenocarcinoma of the prostate



• Documented disease progression based on prostate-specific antigen (PSA) progression during first-line androgen suppression (luteinizing hormone-releasing hormone agonist or orchiectomy)
  • PSA progression is defined by the following:
    • Interval of at least 1 week between reference value (time point value 1) and the next PSA level (time point value 2)
    • PSA at time point value 3 is greater than PSA at time point value 2

      OR

    • PSA at time point value 3 is not greater than PSA at time point value 2, but PSA at time point value 4 is greater than PSA at time point value 2



• PSA at least 5 ng/mL



• Must continue primary androgen suppression if no prior surgical castration



• No known leptomeningeal or brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No prior antibody or gene therapy

Chemotherapy:

• No prior cytostatic agents

Endocrine therapy:

• See Disease Characteristics
• No prior estramustine
• No prior antiandrogens (e.g., bicalutamide)
• No concurrent estrogen-containing medicine

Radiotherapy:

• More than 4 weeks since prior radiotherapy
• No concurrent radiotherapy to more than 1 field

Surgery:

• See Disease Characteristics

Other:

• At least 4 weeks since prior investigational drugs

Patient Characteristics:

Age:

• 18 and over

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm³
• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No acute concurrent severe infection
• No other concurrent significant disease that would preclude study therapy
• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer

Expected Enrollment

A total of 20-62 patients (10-31 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Marco Bonomo, MD, Protocol chair(Contact information may not be current)		Ph: 41-91-646-0101

Registry Information
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
Trial Start Date		2001-08-31
Registered in ClinicalTrials.gov		NCT00031889 1
Date Submitted to PDQ		2002-01-16
Information Last Verified		2006-05-03

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00031889