Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial
- Determine whether fulvestrant can slow the rise of prostrate-specific antigen (PSA)
level in patients with early recurrent adenocarcinoma of the prostate after radical
prostatectomy or irradiation.
- Determine the utility of monitoring serum PSA in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine changes in bone mineral density and markers of bone resorption in patients
with PSA-only failure treated with this drug.
OUTLINE: This is a parallel group study. Patients are stratified according to prior primary
therapy (prostatectomy with or without radiotherapy vs definitive radiotherapy alone).
Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a
month in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study
within 3 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Whether fulvestrant can slow the rise in prostate-specific antigen (PSA) for survival
Donald L. Trump, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|