RATIONALE: Cyproterone acetate may be effective treatment for hot flashes following surgical
or chemical castration for prostate cancer. It is not yet known which regimen of cyproterone
acetate is more effective for hot flashes.
PURPOSE: Randomized phase III trial to determine the effectiveness of cyproterone acetate in
treating patients who have hot flashes following surgical or chemical castration for
- Determine the efficacy of cyproterone acetate in patients with hot flashes following
bilateral orchiectomy or medical castration for prostate cancer.
- Compare the effectiveness of two doses of cyproterone acetate in these patients.
- Determine the safety of this regimen in these patients.
- Determine the impact of this regimen on the quality of life of these patients.
OUTLINE: This is a randomized, double-blind, placebo controlled study.
Patients receive one of two doses of oral cyproterone acetate or placebo for 12 weeks,
followed by a 6-9 month open label extension period with all patients receiving cyproterone
Quality of life is assessed.
PROJECTED ACCRUAL: Not specified
- 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
- Present at least 1 month prior to study
- 18 and over
- ECOG 0-1
- Greater than 12 months
- WBC at least 3,000/uL
- Platelet count at least 75,000/uL
- Hemoglobin at least 6.2 mmol/L
- 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
- BUN no greater than 42 mg/dL
- Creatinine no greater than 3.39 mg/dL
- No cardiovascular risks (e.g., history of angina pectoris) unless controlled by
medical or surgical therapy
- No known history of thromboembolic disease
- 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:
- Not specified
- At least a 4 week washout period is required if prior antineoplastic or cytotoxic
chemotherapy has been used
- 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.,
- Not specified
- See Disease Characteristics
- At least a 4 week washout period is required if prior clonidine or monoamine oxidase
inhibitors have been used