Clinical trial NCT03147196: Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Official title: Neoadjuvant Treatment of Prostate Cancer With Bicalutamide and Raloxifene Prior to Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stage I Prostate Adenocarcinoma
Stage II Prostate Adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-10
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Collection and interrogation of prostate cancer samples
timeFrame: Up to 5 years
Secondary outcomes:
measure: Change in cancer stage/grade via surgical pathology
timeFrame: Baseline up to the time of prostatectomy
measure: Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
timeFrame: Up to 30 days
measure: Percent change in PSA assessed by Prostate Cancer Clinical Trials Working Group
timeFrame: Baseline up to 12 weeks
measure: Tolerance of therapy
timeFrame: Up to 60 days
Other outcomes:
measure: Change in quality of life assessed using the 6-item Linear Analogue Self-Assessment and the Hormonal Domain scale of the Expanded Prostate Cancer Index Composite survey
timeFrame: Baseline up to 5 years
measure: Change in specific pathways and biomarkers
timeFrame: Baseline up to 5 years
Locations:
Study officials:
affiliation: Mayo Clinic
name: Erik Castle
role: PRINCIPAL_INVESTIGATOR
References: