Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
- 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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility of administering chemotherapy and medical castration to men with rising PSA after radical prostatectomy or radiation therapy.
Mary-Ellen Taplin, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|