In this study researcher want to gain more information on how the study drug (radium-223) is distributed in the bone, particularly in the tumor free bone in participants with prostate cancer. The study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Drug will be administered as aqueous solution intravenously at a dose of 55 kBq/kg body weight every 4 weeks for 6 cycles (cycle length = 4 weeks).
Uniklinikum Salzburg - Landeskrankenhaus
Salzburg, Austria
ICM - Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain, France
Institut Claudius Regaud - iUCT Oncopole
Toulouse, France
Rambam Health Corporation
Haifa, Israel
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
Reggio Emilia, Emilia-Romagna, Italy
National Cancer Institute
Vilnius, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, United Kingdom
...and 2 more locations
AUC of radium-223 in tumor-free bone after 3 doses
The uptake of radium-223 in bone is determined with single-photon emission tomography / computed tomography (SPECT/CT).
Time frame: At 4, 24 and 144 hours post injection at Cycle 3 ( total duration of one cycle is 28 days).
AUC of radium-223 in tumor-free bone after single dose
Time frame: At 4, 24 and 144 hours post injection at Cycle 1 ( total duration of one cycle is 28 days).
AUC of radium-223 in tumor-free bone after 6 doses
Time frame: At 4, 24 and 144 hours post injection at Cycle 6 ( total duration of one cycle is 28 days).
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