Status:
COMPLETED
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Walter Reed Army Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 r...
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 De...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01250717
Start Date
January 1 2001
End Date
May 1 2011
Last Update
February 4 2014
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115