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RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers

NCT04037358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-12-19

Study results available
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Summary

This is a Phase II non-blinded randomized study evaluating men with oligometastatic prostate cancer lesions randomized (1:1) to stereotactic ablative radiation therapy (SABR) versus SBAR + Radium-223. We are looking to determine the progression-free survival of men who have oligometastatic prostate cancer with at least one bone metastasis with stereotactic ablative radiation therapy (SABR) versus SABR + Radium-223.

Conditions

Interventions

DRUG

Radium-223

Radium-223 plus SABR will be within two weeks.

RADIATION

stereotactic ablative radiotherapy (SABR)

SABR 1-5 fractions

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Bayer

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Ana Kiess, M.D. · Johns Hopkins SKCCC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2025-07-15
Completion
2025-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04037358 on ClinicalTrials.gov