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

NCT00005623 | Completed Phase 3

• 2 other identifiers: CDR0000067765BARR-PCA-301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes; Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer; hot flashes

Interventions

cyproterone acetate DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barr Laboratories: lead

Study Sites (1)

Barr Laboratories, Incorporated

Pomona, New York, 10970-0519, United States

Location

MeSH Terms

Conditions

Hot Flashes; Prostatic Neoplasms

Interventions

Cyproterone Acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyproterone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Ronald W. Lewis, MD

  MBCCOP - Medical College of Georgia Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 1999
• Study Completion: January 1, 2004
• Last Updated: March 26, 2013

Record last verified: 2003-12

Locations

US (1)