A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer

NCT03574571 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2026-05-14

No results posted yet for this study

Summary

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.

Conditions

Interventions

DRUG

Docetaxel 75 mg/m2

Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses.

DRUG

Docetaxel 60 mg/m2

Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses.

DRUG

Radium-223

Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Sponsors & Collaborators

Principal Investigators

  • Michael Morris, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Netherlands
  • Spain

Study Locations

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Entities

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 NCT03574571 on ClinicalTrials.gov