NCT00005623已完成3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •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
- •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
- •Cardiovascular:
- •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:
- •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
- •See Disease Characteristics
- •At least a 4 week washout period is required if prior clonidine or monoamine oxidase inhibitors have been used
排除标准
- 未提供
研究者
研究点 (1)
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