Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00165399|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 25, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Prostate Cancer||Drug: Docetaxel Drug: Estramustine Drug: Casodex Drug: Zoladex||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment|
|Actual Study Start Date :||March 2004|
|Actual Primary Completion Date :||December 31, 2005|
|Actual Study Completion Date :||December 31, 2005|
- Drug: Docetaxel
Given intravenously on day 2 of four three-week cycles
- Drug: 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 months
- Drug: 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.
- 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 ]
- To determine the PSA response rate and duration of response
- to measure testosterone, free testosterone, and sex hormone binding globulin in relation to chemotherapy and hormone therapy. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165399
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Burlington, Massachusetts, United States, 01805|
|University of Massachusetts Memorial Medical Center-University Campus|
|Worcester, Massachusetts, United States, 01655|
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 037566-0002|
|Principal Investigator:||Mary-Ellen Taplin, MD||Dana-Farber Cancer Institute|