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| Sponsor: | University of California, Irvine |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00598858 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Docetaxel plus prednisone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 35 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles
|
Drug: Docetaxel plus prednisone
Docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | John Fruehauf, MD | Chao Family Comprehensive Cancer Center |
More Information
| Responsible Party: | University of California, Irvine - Chao Family Comprehensive Cancer Center ( John Fruehauf, MD ) |
| Study ID Numbers: | UCI 07-14 |
| Study First Received: | January 10, 2008 |
| Last Updated: | March 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00598858 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
prostate cancer Prostatectomy |
|
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Glucocorticoids Hormones Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |