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Home > "C" Clinical Trials Conditions > Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer  Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
For Condition: stage 4 prostate cancer,Hot Flashes,recurrent prostate cancer,Quality of Life
Status: Completed
Sponsor(s): Barr Laboratories ,
Synopsis: 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.
Details: 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
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldLewis, Study Chair, Medical College of Georgia Comprehensive Cancer Center
Barr Laboratories, Incorporated
Pomona, New York, 10970-0519
United States
Additional Information:
Study ID Numbers: CDR0000067765; BARR-PCA-301
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005623
Other Quality Of Life Studies:
1. PET Scan in Treating Patients With Metastatic Prostate Cancer
2. Vaccine Therapy in Treating Patients With Progressive Prostate Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
4. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
5. Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
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Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
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