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

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

October 31, 2019

Study Completion Date

December 31, 2020

Conditions
Prostate CancerCastration-resistant Prostate CancerCastration-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.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Massachusetts General Hospital

OTHER