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| Sponsor: | Barr Laboratories |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005623 |
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 III |
| 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 |
| 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
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00005623 History of Changes |
| Other Study ID Numbers: | CDR0000067765, BARR-PCA-301 |
| Study First Received: | May 2, 2000 |
| Last Updated: | August 19, 2009 |
| Health Authority: | United States: Federal Government |
|
stage IV prostate cancer recurrent prostate cancer hot flashes |
|
Prostatic Neoplasms Hot Flashes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Signs and Symptoms Cyproterone Acetate Cyproterone |
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 |