Clinical trial · Interventional

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

Neoadjuvant Treatment of Prostate Cancer With Bicalutamide and Raloxifene Prior to Radical Prostatectomy

NCT03147196CI-TRIAL-00036656withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): lack of accrual

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Stage II Prostate Adenocarcinoma	Prostate Adenocarcinoma	CURATED_BROADER	0.78
Stage I Prostate Adenocarcinoma	Prostate Adenocarcinoma	CURATED_BROADER	0.78

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Bicalutamide	Drug	Bicalutamide	ALIAS
Laboratory Biomarker Analysis	Other	—	UNRESOLVED
Questionnaire Administration	Other	—	UNRESOLVED
Raloxifene Hydrochloride	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Arm A (raloxifene hydrochloride)
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.
interventionNames
1. Other: Laboratory Biomarker Analysis
2. Other: Questionnaire Administration
3. Drug: Raloxifene Hydrochloride
type
EXPERIMENTAL
label
Arm B (bicalutamide)
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.
interventionNames
1. Drug: Bicalutamide
2. Other: Laboratory Biomarker Analysis
3. Other: Questionnaire Administration

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 40 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.