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

Mayo Clinic

Status and phase: Withdrawn; Phase 2

Conditions: Stage I Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma

Treatments: Drug: Raloxifene Hydrochloride; Other: Questionnaire Administration; Drug: Bicalutamide; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03147196

P30CA015083 (U.S. NIH Grant/Contract)

MC1552 (Other Identifier)

NCI-2017-00773 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To collect and interrogate samples in patients with prostate cancer that were diagnosed with prostate cancer and are planned for radical prostatectomy at Mayo Clinic Arizona.

SECONDARY OBJECTIVES:

I. To describe the adverse event profile and tolerance of therapy for 60 days of treatment prior to surgery.

II. To assess change in stage and/or grade of cancer and prostate specific antigen (PSA) response to neoadjuvant treatment in patients with hormone sensitive prostate cancer.

TERTIARY OBJECTIVES:

I. To evaluate specific pathways and changes when comparing biopsy specimens to prostatectomy.

II. To describe the quality of life of patients receiving hormonal therapy prior to radical prostatectomy.

OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 4 arms.

ARM A: Patients receive low dose raloxifene hydrochloride orally (PO) daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

ARM D: Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Arm A (raloxifene hydrochloride)

Experimental group

Description:

Patients receive low dose raloxifene hydrochloride PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: Laboratory Biomarker Analysis

Drug: Raloxifene Hydrochloride

Other: Questionnaire Administration

Arm B (bicalutamide)

Experimental group

Description:

Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: Laboratory Biomarker Analysis

Drug: Bicalutamide

Other: Questionnaire Administration

Arm C (raloxifene hydrochloride, bicalutamide)

Experimental group

Description:

Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: Laboratory Biomarker Analysis

Drug: Bicalutamide

Drug: Raloxifene Hydrochloride

Other: Questionnaire Administration

Arm D (raloxifene hydrochloride, bicalutamide)

Experimental group

Description:

Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: Laboratory Biomarker Analysis

Drug: Bicalutamide

Drug: Raloxifene Hydrochloride

Other: Questionnaire Administration