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A Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer

NCT02346526 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-09-29

Study results available
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Summary

The purpose of this study is to look for markers of how Ra-223 improves the lives of men with prostate cancer. This study makes use of Ra-223 in the standard FDA-approved way, but adds non-standard testing in an attempt to gain insight about how the drug works and how best to track patients who are receiving the drug.

Conditions

  • Prostate Cancer
  • Castration-resistant Prostate Cancer
  • Castration-resistant Prostate Cancer Metastatic to Bone

Interventions

PROCEDURE

Blood Tests

Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

PROCEDURE

CT scan

Standard CT scans will be carried out prior to treatment, week 9, and week 25.

PROCEDURE

FACBC PET/MRI in a subset of participants

Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

DRUG

Radium-223 dichloride

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

PROCEDURE

bone scan

Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Philip J Saylor, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-10-31
Completion
2020-12-31

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 NCT02346526 on ClinicalTrials.gov