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Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer

NCT03737370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-10-07

No results posted yet for this study

Summary

The objective of this study is to determine the maximum safe dose of Ra-223 in combination with fractionated (split doses) docetaxel when given to subjects and to determine the best administering dose. The study will look at side effects that may happen while taking the combination treatment. A total of approximately 18 subjects will take part in the dose escalation part of the study and an additional 25 subjects will participate in the expansion cohort. This study will be conducted across four centers in the United States.

Conditions

  • Metastatic Castrate Resistant Prostate Cancer

Interventions

DRUG

Docetaxel

Docetaxel will be administered every 2 weeks (on Day 1 and Day 15 of a 28 day cycle). Fractionated dosing dependent on cohort.

RADIATION

Radium 223

Radium 223 will be delivered every 28 days (on day 1) for 6 cycles.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Lahey Clinic

    collaborator OTHER

  • Henry Ford Hospital

    collaborator OTHER

  • Ohio State University Comprehensive Cancer Center

    collaborator OTHER

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Paul Mathew, MD · Tufts Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2024-12-31
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
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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 NCT03737370 on ClinicalTrials.gov