Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
- Participants will receive treatment in the outpatient clinic, where the docetaxel
chemotherapy will be placed in a bag of fluid and will be given by vein every three
weeks. Participants will take Decadron (dexamethasone) by mouth 12 hours and 1 hour
before docetaxel and again 12 hours after docetaxel. They will also take estramustine
and casodex by mouth at home. Zoladex (or lupron) will be given subcutaneously (under
the skin) 4 times every three months. They will also be started on coumadin beginning
at the time of the first docetaxel infusion and continuing until 3 weeks after the 4th
cycle of chemotherapy.
- After 2 months (or cycles) of therapy, participants will be evaluated in order to
assess the response and toxicity of treatment, including a review of medical history,
physical examination, blood tests, including PSA. If there is no evidence of
progression or excessive toxicity, treatment will continue for 2 more months in the
- At the end of 4 months of chemotherapy, participants will be reassessed by the medical
oncologist and urologist regarding surgery to remove the prostate.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response
Define the pathologic complete response rate in this patient population. Pathologic CR rate of 10% of higher would be a significant finding which warrants further study.
Glenn J. Bubley, MD
Beth Israel Deaconess Medical Center
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|