Hot Flashes, Prostate Cancer
Conditions
Keywords
stage IV prostate cancer, recurrent prostate cancer, hot flashes
Brief summary
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 prostate cancer.
Detailed description
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
Interventions
PROCEDUREquality-of-life assessment
Sponsors
Barr Laboratories
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed