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Spots Global Cancer Trial Database for Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer

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Trial Identification

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

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

Study ID: NCT01050842

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Mayo Clinic In Arizona, Scottsdale, Arizona, United States

Contact Details

Name: Erik P. Castle, M.D.

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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