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Sponsors and Collaborators: |
University of California, Irvine Sanofi-Aventis |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00598858 |
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 |
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Prostate Cancer |
Drug: Docetaxel plus prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
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: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles
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Drug: Docetaxel plus prednisone
Docetaxel (75 mg/m2) every 21 days plus prednisone 5mg twice a day for a total of 3 cycles
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center | 1-877-UC-STUDY | UCstudy@uci.edu |
United States, California | |
Chao Family Comprehensive Cancer Center | Recruiting |
Orange, California, United States, 92868 | |
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center 877-827-8839 UCstudy@uci.edu |
Principal Investigator: | John Fruehauf, MD | Chao Family Comprehensive Cancer Center |
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: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00598858 History of Changes |
Health Authority: | United States: Institutional Review Board |
prostate cancer Prostatectomy |
Anti-Inflammatory Agents Prednisone Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Urogenital Neoplasms Genital Diseases, Male Glucocorticoids Hormones Docetaxel Prostatic Neoplasms |
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 |