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

March 25, 2013 updated by: Barr Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Pomona, New York, United States, 10970-0519
        • Barr Laboratories, Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barr Laboratories

Investigators

  • Study Chair: Ronald W. Lewis, MD, MBCCOP - Medical College of Georgia Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067765
  • BARR-PCA-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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