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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 10, 2008 | ||||
| Last Updated Date | August 11, 2009 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To evaluate PSA response to neoadjuvant docetaxel in patients with stage I /II prostate cancer, who are scheduled for prostatectomy. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00598858 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To identify potential gene expression patterns in the prostate that may predict the response of neoadjuvant docetaxel. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate | ||||
| Official Title ICMJE | Pilot Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response | ||||
| Brief Summary | The purpose of this research study is to evaluate the response to docetaxel in patients with stage I/II prostate cancer, who are scheduled for prostatectomy. Patients will receive docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles. Patients will be treated for approximately two months. At a baseline visit, patients will have endorectal MRI, digital rectal examination, complete chemistries, pathological diagnosis, and serum testosterone and prostate-specific antigen level measurements. Patients will be seen every three week for assessment of toxicity, physical examination, and complete blood count. Once a month, patients will have repeat digital rectal examination, complete chemistries, and serum testosterone and prostate-specific antigen level measurements. After 3 cycles of chemotherapy, patients will be reevaluated with endorectal MRI and serum PSA and then be proceeded to radical prostatectomy. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Drug: Docetaxel plus prednisone | ||||
| Study Arms / Comparison Groups | Experimental: Docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles | ||||
| Publications * | |||||
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* 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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 35 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00598858 | ||||
| Responsible Party | John Fruehauf, MD, University of California, Irvine - Chao Family Comprehensive Cancer Center | ||||
| Study ID Numbers ICMJE | UCI 07-14 | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE | Sanofi-Aventis | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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