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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Hot Flashes, Prostate Cancer

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Trial Information

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


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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Ronald W. Lewis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

MBCCOP - Medical College of Georgia Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067765

NCT ID:

NCT00005623

Start Date:

December 1999

Completion Date:

January 2004

Related Keywords:

  • Hot Flashes
  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • hot flashes
  • Prostatic Neoplasms
  • Hot Flashes

Name

Location

Barr Laboratories, IncorporatedPomona, New York  10970-0519