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

NCT03147196 | Withdrawn Phase 2 DMC FDA Drug

• 3 other identifiers: MC1552NCI-2017-00773P30CA015083
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stage I Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Collection and interrogation of prostate cancer samples

  Pathways and biomarkers will be compared to similar analyses that have been and will be performed on in vitro and in vivo experiments. Point estimates and two-sided 95% confidence intervals will be computed.

  Up to 5 years

Secondary Outcomes (4)

• Change in cancer stage/grade via surgical pathology

  Baseline up to the time of prostatectomy

• Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  Up to 30 days

• Percent change in PSA assessed by Prostate Cancer Clinical Trials Working Group

  Baseline up to 12 weeks

• Tolerance of therapy

  Up to 60 days

Other Outcomes (2)

• 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

  Baseline up to 5 years

• Change in specific pathways and biomarkers

  Baseline up to 5 years

Study Arms (4)

Arm A (raloxifene hydrochloride)

EXPERIMENTAL

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.

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

Arm B (bicalutamide)

EXPERIMENTAL

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.

Drug: Bicalutamide; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Arm C (raloxifene hydrochloride, bicalutamide)

EXPERIMENTAL

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.

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

Arm D (raloxifene hydrochloride, bicalutamide)

EXPERIMENTAL

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.

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

Interventions

Bicalutamide DRUG

Given PO

Also known as: Casodex, Cosudex, ICI 176,334, ICI 176334

Arm B (bicalutamide); Arm C (raloxifene hydrochloride, bicalutamide); Arm D (raloxifene hydrochloride, bicalutamide)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (raloxifene hydrochloride); Arm B (bicalutamide); Arm C (raloxifene hydrochloride, bicalutamide); Arm D (raloxifene hydrochloride, bicalutamide)

Questionnaire Administration OTHER

Ancillary studies

Arm A (raloxifene hydrochloride); Arm B (bicalutamide); Arm C (raloxifene hydrochloride, bicalutamide); Arm D (raloxifene hydrochloride, bicalutamide)

Raloxifene Hydrochloride DRUG

Given PO

Also known as: Evista, Keoxifene Hydrochloride, LY-156758, Optruma, Raloxifene HCl, Raloxifene.HCl

Arm A (raloxifene hydrochloride); Arm C (raloxifene hydrochloride, bicalutamide); Arm D (raloxifene hydrochloride, bicalutamide)

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Interventions

bicalutamide; Raloxifene Hydrochloride

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Erik Castle

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: June 27, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 22, 2019

Record last verified: 2019-01