Conditions: Prostate Cancer
Keywords: prostatectomy docetaxel
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 28
Healthy volunteers: no

Brief summary:
The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

Detailed description:
* 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 same manner.
* At the end of 4 months of chemotherapy, participants will be reassessed by the medical oncologist and urologist regarding surgery to remove the prostate.

Arms:
arm 1: Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy

Interventions: intervention 1: Docetaxel intervention 2: Dexamethasone intervention 3: Estramustine intervention 4: Zoladex intervention 5: Casodex intervention 6: Radical Prostatectomy
Intervention descriptions: intervention 1: Given by an IV infusion over 1 hour on day 2 of a three-week cycle intervention 2: Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel intervention 3: Taken orally three times a day for 5 days for the first part of every three week cycle intervention 4: Given subcutaneously for 4 doses every three months intervention 5: Taken orally once a day for 6 months intervention 6: after the chemo and hormonal therapy all patients have a radiacal prostatectomy

Protocol document: