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Brief Title: Fulvestrant in Treating Patients With Advanced Prostate Cancer
Official Title: Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer
Study ID: NCT00244998
Brief Summary: 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 advanced prostate cancer.
Detailed Description: OBJECTIVES: Primary * Determine if the prostate-specific antigen objective response (complete and partial response) rate is \> 0.2 in patients with androgen-independent advanced prostate cancer treated with fulvestrant. Secondary * Determine the toxicity of this drug in these patients. OUTLINE: This is an open-label study. Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Courses repeat once a month in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for survival. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Roswell Park Cancer Institute, Buffalo, New York, United States
Name: Donald L. Trump, MD
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR