NCT00217464

Fulvestrant in Treating Patients With Recurrent Prostate Cancer

Multicenter Study of Fulvestrant (Faslodex®) in Early, Recurrent Prostate Cancer Following Local Therapy: A Phase II Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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 recurrent prostate cancer.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	fulvestrant	intramuscularly

Timeline

• Start date: 2004-06-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2005-09-22
• Last updated: 2015-04-16
• Results posted: 2015-04-16

Locations

1 site across 1 country: United States