A Phase III, Randomized, Multicenter, Placebo-Controlled, Double-Blind Clinical Trial to Study the Efficacy and Safety of CyPat (Cyproterone Acetate [CA]) for the Treatment of Hot Flashes Following Surgical or Chemical Castration of Prostate Cancer Patients and Its Impact on the Quality of Life in These Patients

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Prostate cancer patients who have undergone bilateral orchiectomy or medical
castration (LHRH agonist drugs) and are experiencing hot flashes

- Hot flashes are defined as:

- At least 3 to 4 moderate to severe hot flashes per day or 21 per week at
baseline

- Present at least 1 month prior to study

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Greater than 12 months

Hematopoietic:

- WBC at least 3,000/uL

- Platelet count at least 75,000/uL

- Hemoglobin at least 6.2 mmol/L

Hepatic:

- Bilirubin no greater than 1.8 mg/dL

- SGPT no greater than 96 u/L

- SGOT no greater than 90 u/L

- LDH no greater than 600

Renal:

- BUN no greater than 42 mg/dL

- Creatinine no greater than 3.39 mg/dL

Cardiovascular:

- No cardiovascular risks (e.g., history of angina pectoris) unless controlled by
medical or surgical therapy

- No known history of thromboembolic disease

Other:

- Comprehend and understand English language

- No other prior malignancy within the past 5 years except treated squamous or basal
cell skin cancer or superficial bladder carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least a 4 week washout period is required if prior antineoplastic or cytotoxic
chemotherapy has been used

Endocrine therapy:

- At least a 4 week washout period is required if prior estrogens, antiandrogens (e.g.,
flutamide or bicalutamide), progestational agents, or corticosteroids have been used

- No concurrent herbal medications with known hormonal ingredients (i.e.,
phytoestrogens)

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

Other:

- At least a 4 week washout period is required if prior clonidine or monoamine oxidase
inhibitors have been used