Hot FlashesPhase 3NCT00005623
Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer
A Phase 3 study testing cyproterone acetate and quality-of-life assessment in people with Hot Flashes and Prostate Cancer, run by Barr Laboratories at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hot Flashes, Prostate Cancer
- What is being tested?
- cyproterone acetate and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barr Laboratories, Incorporated
Pomona, New York, 10970-0519
About this study
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
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.
Read the 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
- Conditions
- Hot Flashes, Prostate Cancer
- Being tested
- cyproterone acetate, quality-of-life assessment
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, hot flashes
- Medical subject headings
- Hot Flashes, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyproterone acetateDrug
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 1999
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Barr Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ronald W. Lewis, MD, Study chair, MBCCOP - Medical College of Georgia Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005623
- Sponsor's protocol ID
- CDR0000067765
- Other IDs
- BARR-PCA-301
- Status last verified
- Dec 2003
- First submitted
- 2 May 2000
- Last updated
- 26 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00005623
- Acronym / sponsor ID
- CDR0000067765
- Conditions
- Hot Flashes, Prostate Cancer
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, hot flashes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Barr LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Dec 1999
- Study completion
- Jan 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyproterone acetate | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald W. Lewis, MD study chair
MBCCOP - Medical College of Georgia Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyproterone acetate and quality-of-life assessment in people with Hot Flashes and Prostate Cancer, run by Barr Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013.