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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005623
First received: May 2, 2000
Last updated: March 25, 2013
Last verified: December 2003
  Purpose

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.


Condition Intervention Phase
Hot Flashes
Prostate Cancer
Drug: cyproterone acetate
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1999
Study Completion Date: January 2004
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005623

Locations
United States, New York
Barr Laboratories, Incorporated
Pomona, New York, United States, 10970-0519
Sponsors and Collaborators
Barr Laboratories
Investigators
Study Chair: Ronald W. Lewis, MD MBCCOP - Medical College of Georgia Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005623     History of Changes
Other Study ID Numbers: CDR0000067765, BARR-PCA-301
Study First Received: May 2, 2000
Last Updated: March 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
recurrent prostate cancer
hot flashes

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Cyproterone
Cyproterone Acetate
Diane
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 17, 2014