Cyproterone Acetate in Treating Patients With Newly Diagnosed Stage III or Stage IV Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00363285|
Recruitment Status : Unknown
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 15, 2006
Last Update Posted : August 26, 2013
|First Submitted Date ICMJE||August 10, 2006|
|First Posted Date ICMJE||August 15, 2006|
|Last Update Posted Date||August 26, 2013|
|Study Start Date ICMJE||January 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00363285 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Cyproterone Acetate in Treating Patients With Newly Diagnosed Stage III or Stage IV Prostate Cancer|
|Official Title ICMJE||Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer|
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving cyproterone acetate continuously is more effective than giving cyproterone acetate after tumor progression in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well it works when given continuously or after tumor progression in treating patients with newly diagnosed stage III or stage IV prostate cancer.
OUTLINE: This is a randomized, multicenter study.
All patients receive cyproterone acetate daily for 16 weeks. Patients also receive monthly injections of luteinizing hormone-releasing hormone (LHRH) agonist beginning in week 2 and continuing for 14 weeks. Patients with a prostate-specific antigen (PSA) level of ≤ 4 ng/mL and who are asymptomatic at 14 weeks are randomized to 1 of 2 treatment arms.
Quality of life is assessed every 6 months for 2 years and then annually thereafter.
Quality of life is assessed every 6 months and when therapy is restarted.
Pain and performance status are assessed at each visit in both treatment arms.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Prostate Cancer|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||up to 79 Years (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00363285|
|Other Study ID Numbers ICMJE||CDR0000495321
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||St. Bartholomew's Hospital|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||October 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP