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

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Bicalutamide; Exemestane

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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3

• Neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• 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

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