Scientists track how prostate cancer drug travels in bones
NCT ID NCT04521361
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looked at how the drug radium-223 spreads in the bones of men with prostate cancer that has spread to bones. Researchers gave the drug intravenously every 4 weeks for up to 6 doses and used imaging scans to measure its distribution in both tumor and healthy bone. The goal was to learn more about where the drug goes, not to test if it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radium-223 dichloride (Xofigo)
- What this could lead to
- If successful, this could help doctors better understand how radium-223 targets bone tumors, potentially improving future treatment plans for prostate cancer that has spread to bones.
- What could go wrong
- This is a small, early-phase study focused on measuring drug distribution, not on proving effectiveness. Results may not lead to direct treatment changes or benefits for participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
46 people
The number who actually took part.
- Started
-
Nov 2020
- Finished
-
Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants who have histologically confirmed adenocarcinoma of the prostate. * Participants with bone metastatic CRPC, progressing after 1 or 2 prior lines of systemic treatment for metastatic prostate cancer (including prior treatment for metastatic hormone sensitive prostate mHSPC or metastatic castration resistant prostate cancer mCRPC). * Participants with at least 2 bone metastases on Tc 99m phosphonate whole body planar bone scans at Screening. * Documented progression of mCRPC. Disease progression is defined by at least one of the following criteria: a. PCWG3 criteria (defined as 2 consecutive increases in PSA over a previous reference value measured at least one week prior, with a minimal start value of 1.0 ng/mL) or b. ≥2 new bone lesions (according to PCWG3 bone scan criteria) or c. Radiological progression according to RECIST, version 1.1. * Ability to participate in the required study procedures including all scanning procedures and ability to control pain to ensure tolerance and completion of the necessary scanning procedures. * Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L). If the participant is being treated with luteinizing hormone releasing hormone (LHRH) agonists or antagonists (participant who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to start of Screening and must be continued throughout the study. * Participants must be on a bone health agent prior to the first dose of radium-223 dichloride. Participants with at least 6 months of prior bone health agent (BHA) treatment are preferred. * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. * Life expectancy ≥6 months. Exclusion Criteria: * Any chronic medical condition requiring continuous systemic corticosteroid treatment at a higher dose than 5 mg prednisone / prednisolone twice daily. * Pathological finding consistent with neuroendocrine features small cell carcinoma of the prostate. * Metastatic bone deposits extend of disease (EOD) grades 0 or 4 (according to centrally assessed Tc 99m phosphonate planar bone scans during Screening). * History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations (according to central review at screening). * Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). * Imminent spinal cord compression based on clinical findings and / or magnetic resonance imaging (MRI). - Participants with history of spinal cord compression should have completely recovered. * Active or symptomatic viral hepatitis * Inability to tolerate any of the other imaging procedures in the study (ie, bone SPECT/CT and planar bone scans with a Tc 99m phosphonate radiotracer, DXA scan, radium-223 SPECT/CT scans). * Any condition, which in the opinion of the investigator would preclude participation in this trial. * Hypersensitivity to radium-223 dichloride. * Blood transfusion or erythropoietin stimulating agents 4 weeks prior to start of Screening and during the whole Screening period before enrollment into the cohort. * Prior administration of an investigational therapeutic for CRPC.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bone metastatic castration-resistant prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
Reggio Emilia, Emilia-Romagna, 42123, Italy
-
Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital
London, SE1 7EH, United Kingdom
-
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
-
ICM - Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, 34298, France
-
Institut Claudius Regaud - iUCT Oncopole
Toulouse, 31059, France
-
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain, 44800, France
-
National Cancer Institute
Vilnius, LT-08660, Lithuania
-
Rambam Health Corporation
Haifa, 3109601, Israel
-
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, SM2 5PT, United Kingdom
-
Uniklinikum Salzburg - Landeskrankenhaus
Salzburg, 5020, Austria
-
University College London Hospitals NHS Foundation Trust
London, NW1 2PG, United Kingdom
-
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661, Lithuania