Loading clinical trials...

COMPLETEDPHASE1

A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones

Open-label, Non-randomized Phase 1, Multicenter Study to Assess Radium-223 Biodistribution in Participants With Bone Metastatic Castration Resistant Prostate Cancer (CRPC) Receiving Radium-223 Dichloride Treatment.

NCT04521361•Bayer

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.
+2 more criteria

Locations (12)

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

Key Dates

Start Date

November 16, 2020

Primary Completion Date

October 10, 2023

Completion Date

August 27, 2025

Last Updated

September 19, 2025

Enrollment

ACTUAL participants

Conditions

Bone Metastatic Castration-resistant Prostate Cancer

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223)

DRUG

A Study to Learn More About How Radium-223 is Being Used With Other Treatments in European Patients Who Have Not Received Radium-223 Before

NCT04587427

Bone Metastatic Castration-resistant Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions