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Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases

NCT02582749 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-07-11

Study results available
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Summary

Newly diagnosed metastatic prostate cancer subjects with bone metastases will be accrued to this stratified randomized 2-arm Phase II trial. Subjects will be randomized 1:2 to ADT or ADT with Radium-223 dichloride respectively.

Conditions

Interventions

DRUG

LHRH agonist/antagonist

Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.

DRUG

Bicalutamide

Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.

RADIATION

Radium-223 dichloride

Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections

Sponsors & Collaborators

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    collaborator INDUSTRY

  • Ajjai Alva, MD

    lead OTHER

Principal Investigators

  • Ajjai Alva, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-09-14
Completion
2017-09-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582749 on ClinicalTrials.gov