Docetaxel, Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA Progression Free Survival
William Walsh, MD
University of Massachusetts, Worcester
United States: Federal Government
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Lahey Clinic - Burlington||Burlington, Massachusetts 01805|
|University of Massachusetts Memorial Medical Center - University Campus||Worcester, Massachusetts 01655|