Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
This study is ongoing, but not recruiting participants.
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
First received: September 9, 2005
Last updated: February 5, 2013
Last verified: February 2013
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
Adenocarcinoma of the Prostate
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment|
Resource links provided by NLM:
Drug Information available for: Estramustine phosphate sodium Goserelin Bicalutamide Docetaxel Goserelin acetateU.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the PSA response rate and duration of response [ Time Frame: TBD ] [ Designated as safety issue: No ]
- to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Intervention Details:Detailed Description:
Given intravenously on day 2 of four three-week cyclesDrug: Estramustine
Taken orally three times a day for 5 days starting on day one of each three-week cycles (4 cycles)Drug: Casodex
Started 3 weeks after last chemotherapy treatment; taken orally once a day for 15 monthsDrug: Zoladex
Started one week after the start of casodex; zolades is given as an injection (in the stomach once every 3 months for a total of 5 injections.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165399
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
Sponsors and Collaborators
Dana-Farber Cancer Institute
|Principal Investigator:||Mary-Ellen Taplin, MD||Dana-Farber Cancer Institute|