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Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer

Primary Purpose

Hot Flashes, Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cyproterone acetate
quality-of-life assessment
Sponsored by
Barr Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hot Flashes focused on measuring stage IV prostate cancer, recurrent prostate cancer, hot flashes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Barr Laboratories, Incorporated

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
March 25, 2013
Sponsor
Barr Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00005623
Brief Title
Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Barr Laboratories

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Prostate Cancer
Keywords
stage IV prostate cancer, recurrent prostate cancer, hot flashes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyproterone acetate
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W. Lewis, MD
Organizational Affiliation
MBCCOP - Medical College of Georgia Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Barr Laboratories, Incorporated
City
Pomona
State/Province
New York
ZIP/Postal Code
10970-0519
Country
United States

12. IPD Sharing Statement

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Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer

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