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Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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
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.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Potential candidate for radical prostatectomy

- Any of the following: a) clinical stage T3 patients, b) Serum PSA greater than or
equal to 20 ng/ml, c) Gleason score 8-10, d) Clinical T2 disease and either MRI
evidence of seminal vesicle involvement or Gleason 4+3 cancer with either 5 or 6
biopsies positive

- ECOG Performance Status 0-1

- WBC > 3,000 ul

- HCT > 30%

- PLT > 100,000/ul

- LFTS within normal limits

Exclusion Criteria:

- Prior hormones, radiation or chemotherapy for prostate cancer

- Myocardial infarction within 1 year, significant change in anginal pattern within
last 6 months, current congestive heart failure (NYHA Class 2 or higher), or deep
venous thrombosis within 1 year

- Evidence of active infection

- Significant peripheral neuropathy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Glenn J. Bubley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2001

Completion Date:

May 2011

Related Keywords:

  • Prostate Cancer
  • prostatectomy
  • docetaxel
  • Prostatic Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215