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Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
The purpose of this study is to see if the combination of chemotherapy drugs and drugs to suppress testosterone (hormone therapy) is effective in controlling early prostate cancer. This study will attempt to: * stop or slow the growth of disease * gain information about prostate cancer * evaluate the effectiveness and side effects of the study drug
* Patients will receive two medications; docetaxel and estramustine. Estramustine will be taken orally three times daily for 5 days starting on day one. Docetaxel will be given intravenously on day 2. These two drugs will be repeated every 3 weeks for a total of 4 cycles (12 weeks). * Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects. * Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots. * After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment. Three weeks after the last chemotherapy treatment, patients will start Casodex orally once daily. * After taking Casodex for 1 week, patients will then start on Zoladex (an injection in the abdomen) every 3 months for a total of 5 injections. * During study treatment various blood tests will be performed to watch the disease. Study treatment will stop after a total of 18 months (3 months chemotherapy and 15 months hormone therapy). A physical exam and blood tests will be performed every 3 months for 2 years, every 4 months for the third year, and then every 6 months after that.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic-Burlington
Burlington, Massachusetts, United States
University of Massachusetts Memorial Medical Center-University Campus
Worcester, Massachusetts, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Start Date
March 1, 2004
Primary Completion Date
December 31, 2005
Completion Date
December 31, 2005
Last Updated
June 25, 2018
62
ACTUAL participants
Docetaxel
DRUG
Estramustine
DRUG
Casodex
DRUG
Zoladex
DRUG
Lead Sponsor
Dana-Farber Cancer Institute
NCT04550494
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465