Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

• Status: Withdrawn
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bicalutamide; Raloxifene Hydrochloride

Criteria

Inclusion Criteria:

• Histological confirmation of adenocarcinoma of the prostate, >= Gleason 6, clinical stage T1a-T2c and planned for radical prostatectomy

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

• Platelet count >= 50,000/mm^3

• Hemoglobin > 9.0 g/dL

• Creatinine =< 2.0 mg/dL

• Provide informed written consent

• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study); Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up

• Patients must also provide written consent for biospecimens collection on Institutional Review Board (IRB) 08-000980

Exclusion Criteria:

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

• History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

• History of a venous thromboembolic event, cerebrovascular accident (CVA), hepatic impairment, or heart failure