OBJECTIVES:

• 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 acetate.

Quality of life is assessed.

PROJECTED ACCRUAL: Not specified

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