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

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Eligibility 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
Sites / Locations
- Kantonspital Aarau
- University Hospital
- Inselspital, Bern
- Spitalzentrum Biel
- Kantonsspital Bruderholz
- Ratisches Kantons und Regionalspital
- Clinique De Genolier
- Centre Hospitalier Universitaire Vaudois
- Istituto Oncologico della Svizzera Italiana
- Ospedale Beata Vergine
- Institut Central des Hopitaux Valaisans
- Universitaetsspital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm I
Arm II
Patients receive oral exemestane once daily
Patients receive exemestane as in arm I and oral bicalutamide once daily