Clinical Trials Logo

Clinical Trial Summary

This is an observational study in which data from Chinese men with metastatic castration-resistant prostate cancer that has spread to the bones and who start Radium-223 therapy is studied. When tumors form in the prostate, male hormones like testosterone will cause the spread and growth of tumors. Men with prostate cancer can have hormonal or surgical treatment that lowers testosterone. But this may not stop the cancer from growing or spreading in some men. When the prostate cancer is no longer responding to therapies aimed at lowering testosterone (castration resistant) and has spread to the bones (metastatic), it is referred to as bone metastatic castration-resistant prostate cancer. The study treatment, Radium-223 (also called Xofigo), gives off radiation that helps to kill cancer cells. It is already approved to be used for men whose prostate cancer has spread to the bone with symptoms, but not to be used for other types of tumors or for prostate cancer that has spread to other parts of the body. Sometimes, after the approval of some drugs, researchers will further study the safety of such approved treatments in patients being treated in routine clinical practice. In this study, researchers want to learn more about the medical problems that may occur in Chinese patients after they start Radium-223 therapy, especially those problems concerning the blood and blood-forming organs. To answer this question, the researchers will observe patients who start Radium-223 as part of their routine care and also collect information of any medical problems happening after Radium-223 injections from the medical records of these patients. These medical problems may or may not be related to Radium-223 and are also known as adverse events. The researchers will assess the percentage of men who developed medical problems concerning the blood and blood-forming organs from the start of Radium-223 injection till up to 6 months after the last Radium-223 injection. The researchers will also collect data on the time the participants live after start of treatment, the change in pain severity, and the time between the end of Radium-223 treatment and the beginning of the following therapy against the cancer. Besides the data collection, no further tests or examinations of any patients or any samples are planned in this study. The participants will start Radium-223 treatment as part of their routine care as prescribed by their doctors according to the recommended use. Data collection of each participant will last until the participant leaves the study or until the study ends. The study is planned to end 6 months after the last included participant receives the last injection of Radium-223.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05301062
Study type Observational
Source Bayer
Contact
Status Terminated
Phase
Start date September 15, 2022
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Active, not recruiting NCT01996046 - FDG PET/CT in Breast Cancer Bone Mets
Completed NCT01358539 - Palliation: the Effect of Education on Pain Phase 3
Terminated NCT00981578 - ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain N/A
Terminated NCT00757757 - A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases Phase 1/Phase 2
Completed NCT00762346 - Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis Phase 4
Completed NCT00420433 - Bone Response in Metastatic Breast Cancer Involving Bones N/A
Completed NCT02826382 - Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041 Early Phase 1
Recruiting NCT06367491 - National Database of Bone Metastases
Completed NCT03223727 - Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Completed NCT00830180 - Open Label Extension In Cancer Patients Phase 2
Active, not recruiting NCT03305224 - The Combination Therapy With Ra-223 and Enzalutamide Phase 2
Withdrawn NCT04109937 - External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial N/A
Active, not recruiting NCT02880943 - Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL) Phase 1/Phase 2
Completed NCT01696760 - Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology N/A
Completed NCT00958477 - A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer Phase 1
Completed NCT03979118 - Exercise Prescription in Patients With Bone Metastases
Completed NCT03353090 - Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients N/A
Recruiting NCT05167669 - Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU Early Phase 1
Recruiting NCT04568291 - CTC in Lung Caner Patients With Bone Metastases N/A