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Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate (2007-5904)

This study is not yet open for participant recruitment.
Information provided by University of California, Irvine

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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.

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:

  • Patient must have a histological diagnosis of adenocarcinoma of the prostate which is measurable or evaluable Stage I or II.
  • Patient must have an ECOG performance status 0-2.
  • Patient must have a pre-study PSA within 28 days prior to start of therapy.
  • Patients who have received prior radiotherapy are not eligible.
  • Patient must have an adequate renal function
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
  • Age > 18
  • Patients must be able to take oral medications

Exclusion Criteria:

  • Patients with measurable metastatic diseases by a CT scan of the abdomen and pelvis within 28 days and by a bone scan within 42 days prior to start of therapy.
  • Patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to start of therapy and must have recovered from toxicities of prior therapy to grade 1 or less with the exception of alopecia.
  • Patients must not be treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole).
  • Patients must not take vitamins, herbs, or micronutrient supplement within 28 days prior to start of therapy.
  • Patients may not have ongoing problems with bowel obstruction or short bowel syndrome characterized by grade 2 or greater diarrhea or malabsorptive disorders.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol.
  • Patients should not have any medical life-threatening complications of their malignancies
  • Patients should not have a known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV).
  • Patients should not have current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
  • Patients with history of myocardial infarction, cerebrovascular accident, transient ischemic attack, or unstable angina within 6 months
  • Patients with clinically significant peripheral vascular disease
  • Patients with evidence of bleeding diathesis or coagulopathy
  • Patients with central nervous system or brain metastases
  • Patients who had major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  • Patients with minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
  • Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
  • Patients with serious, non-healing wound, ulcer, or bone
  • Patients who are diagnosed of any other malignancy except non-melanomatous skin cancer in the past 5 years
  • Patients receiving anticoagulation therapy (e.g. Coumadin) prior to registration
Gender Male
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center     1-877-UC-STUDY     UCstudy@uci.edu    
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 
Principal Investigator:     John Fruehauf, MD     Chao Family Comprehensive Cancer Center    
Information Provided By University of California, Irvine
Verification Date March 2008
First Received Date  January 10, 2008
Last Updated Date March 21, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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