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| Descriptive Information Fields | |||||
| Brief Title † | Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate | ||||
| Official Title † | 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 † | Interventional | ||||
| Study Design † | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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 ] | ||||
| Secondary Outcome Measure † | 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 ] | ||||
| Condition † | Prostate Cancer | ||||
| Intervention † | Drug: Docetaxel plus prednisone | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Not yet recruiting | ||||
| Enrollment † | 35 | ||||
| Start Date † | May 2008 | ||||
| Completion Date | December 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00598858 | ||||
| Organization ID | UCI 07-14 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of California, Irvine | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | January 10, 2008 | ||||
| Last Updated Date | March 21, 2008 | ||||