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Sponsored by: |
Barr Laboratories |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005623 |
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 |
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Cancer-Related Problem/Condition Prostate Cancer |
Drug: cyproterone acetate Procedure: quality-of-life assessment |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
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 Start Date: | December 1999 |
OBJECTIVES:
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hot flashes are defined as:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Barr Laboratories, Incorporated | |
Pomona, New York, United States, 10970-0519 |
Study Chair: | Ronald W. Lewis, MD | MBCCOP - Medical College of Georgia Cancer Center |
Study ID Numbers: | CDR0000067765, BARR-PCA-301 |
Study First Received: | May 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005623 History of Changes |
Health Authority: | United States: Federal Government |
stage IV prostate cancer recurrent prostate cancer quality of life hot flashes |
Genital Neoplasms, Male Prostatic Diseases Contraceptive Agents Hormone Antagonists Cyproterone Acetate Hormones, Hormone Substitutes, and Hormone Antagonists Hot Flashes Cyproterone Quality of Life Urogenital Neoplasms |
Contraceptive Agents, Male Genital Diseases, Male Hormones Recurrence Signs and Symptoms Androgen Antagonists Diane Prostatic Neoplasms Androgens |
Genital Neoplasms, Male Prostatic Diseases Contraceptive Agents Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Cyproterone Acetate Hormones, Hormone Substitutes, and Hormone Antagonists Hot Flashes Cyproterone Urogenital Neoplasms |
Reproductive Control Agents Contraceptive Agents, Male Genital Diseases, Male Pharmacologic Actions Signs and Symptoms Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Diane Prostatic Neoplasms |