NCT00165399

Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment

Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

* 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.

Conditions

• Adenocarcinoma of the Prostate
• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-12-31
• Completion: 2005-12-31
• First posted: 2005-09-14
• Last updated: 2018-06-25

Locations

5 sites across 1 country: United States