Prostate Cancer Clinical Trial
Official title:
Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells.
Hormone therapy using bicalutamide and leuprolide may fight prostate cancer by reducing the
production of androgens.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy consisting of docetaxel
and estramustine plus hormone therapy in treating patients who have previously undergone
radiation therapy or surgical removal of the prostate for stage I prostate cancer.
OBJECTIVES:
- Determine the feasibility of administering docetaxel plus estramustine in combination
with androgen deprivation therapy in patients with PSA elevation following radiotherapy
or radical prostatectomy for early prostate cancer.
- Evaluate this regimen in terms of PSA response rate, response duration, and time to
future therapeutic intervention in this patient population.
- Evaluate testosterone, free testosterone, and sex hormone binding globulin in relation
to this treatment regimen in these patients.
OUTLINE: Patients receive oral estramustine three times a day on days 1-5 and docetaxel IV
over 1 hour on day 2. Treatment repeats every 3 weeks for 4 courses.
Patients receive oral bicalutamide daily beginning on week 12 and leuprolide intramuscularly
every 3 months beginning on week 13. Treatment continues for 15 months.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6
months thereafter until disease progression and/or subsequently until death. Information
will be collected on subsequent prostate cancer treatments, time to and nature of first
evidence of metastatic prostate cancer, and the date and cause of death.
PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study.
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