Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to stop the growth of prostate cancer.
PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating patients with metastatic or hormone-refractory prostate cancer.
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Stage IV Prostate Cancer
Procedure: quality-of-life assessment
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Trial to Evaluate the Safety and Efficacy of the Administration of Bicalutamide (Casodex TM) Per Day in Combination With Raloxifene (Evista TM) Per Day in Patients With Hormone Refractory Prostate Cancer|
- Progression-free survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Adverse events of combined treatment with bicalutamide and raloxifene as measured by CTCAE version 3.0 [ Designated as safety issue: Yes ]
- Quality of life as assessed by Linear Analogue Self Assessment (LASA6) and the Hormonal Domain scale of the Expanded Prostate Cancer Index Composite (EPIC-H) survey [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Measurable or evaluable disease as assessed by RECIST [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral bicalutamide and oral raloxifene on days 1-28.
Other Names:Drug: raloxifene
Other Names:Procedure: quality-of-life assessment
Other Name: quality of life assessment
I. To describe the 6-month progression-free survival rate, progression-free survival, and overall survival of patients receiving bicalutamide and raloxifene.
II. To describe the adverse event profile of combined treatment with bicalutamide and raloxifene (adverse events graded using the NCI CTCAE version 3.0).
III. To describe the quality of life of patients receiving bicalutamide and raloxifene.
OUTLINE: Patients receive oral bicalutamide and oral raloxifene on days 1-28. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3-6 months for up to 3 years.