RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer.
OBJECTIVES: Primary * 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. Secondary * 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 an open-label, single group assignment study. 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 32 patients will be accrued for this study for 84 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
intramuscularly
Roswell Park Cancer Institute
Buffalo, New York, United States
Proportion of Patients Who Respond to Treatment.
Response is defined to be the clear slowing of the rate of increase of PSA levels with time
Time frame: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
Number of Participants With Progressive Disease at Day +90
Progressive Disease is defined as failure to achieve a statistically significant decrease in PSA rise after the day +90 PSA value
Time frame: 90, 60, and 30 days pre-treatment, the day of start therapy (day 0) and 30, 60 and 90 days post-treatment
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