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Tracking Information | |||||
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First Received Date † | September 5, 2007 | ||||
Last Updated Date | March 25, 2008 | ||||
Start Date † | September 2007 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00526591 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer | ||||
Official Title † | Randomized Phase II Study of Two Different Doses of RAD-001 (Everolimus) as Neo-Adjuvant Therapy in Patients With Localized Prostate Cancer | ||||
Brief Summary | RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus works in treating patients with newly diagnosed localized prostate cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Within 7 days after the last dose of everolimus, all patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy. Tumor biopsy specimens acquired prior to treatment and prostate tumor tissue acquired at the time of radical prostatectomy are evaluated for biomarker correlative studies. Tissue samples are assessed by immunohistochemistry (IHC) and tissue microarray analysis for expression of cellular and molecular biomarkers (i.e., p-S6, p-4E-BP1, and p-Akt) that correlate with response. Prostatectomy specimens are also assessed by pathologic analysis for histopathologic response (i.e., pathologic stage, Gleason score, margin status, and tumor size). After completion of study therapy, patients are followed at 6 weeks. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized | ||||
Condition † | Prostate Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Terminated | ||||
Enrollment † | 30 | ||||
Completion Date | |||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00526591 | ||||
Responsible Party | |||||
Secondary IDs †† | CASE-21806, CASE-21806-CC256, NOVARTIS-CASE-21806 | ||||
Study Sponsor † | Case Comprehensive Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | March 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |