NCT01050842

Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: 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.

Conditions

• Prostate Cancer
• Adenocarcinoma of the Prostate
• Hormone-resistant Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	bicalutamide	Given orally
DRUG	raloxifene	Given orally
PROCEDURE	quality-of-life assessment	Ancillary study

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-05-01
• Completion: 2012-10-04
• First posted: 2010-01-15
• Last updated: 2017-03-23

Locations

1 site across 1 country: United States