check_circleStudy Completed
Metastatic castration resistant prostate cancer (mCRPC)
Bayer Identifier:
22564
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
An Observational Study to Learn More About the Use of Radium 223 in Men with Prostate Cancer in the United States
Trial purpose
This is an observational study in which data already collected from men with metastatic castration resistant prostate cancer (mCRPC) in the United States are studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
This is an observational study in which only data are collected from participants who received their usual treatment.
mCRPC is a cancer of the prostate gland (a male reproductive gland found below the bladder) that has spread to other parts of the body. This type of prostate cancer does not respond to hormone treatment, which is used to lower the level of testosterone (male hormone), to prevent cancer from growing.
Radium-223 (Ra-223) has already been approved for the treatment of mCRPC. It is a type of radiation therapy that releases radiation after it is injected into the body, which can damage and slow down the growth of cancer cells.
The main purpose of this study is to learn more about the real-world use of Ra-223 in men with mCRPC in the United States.
To do this, researchers will collect the following information on:
• Number of participants who have completed six treatment cycles of Ra 223. A cycle is a treatment period that is repeated until the treatment is discontinued.
• Factors such as age, sex, and other treatment-related characteristics that can lead to stopping Ra-223 early
The data will come from the participants’ information stored in a database called Komodo Health (KH). Data collected will be from July 2017 to March 2022.
Researchers will only look at the health records from men with mCRPC in the United States.
Researchers will track participants’ data and will follow them for a maximum of 6 months or until the participant decides to leave the study, or the end of the study, or until they die.
This is an observational study in which only data are collected from participants who received their usual treatment.
mCRPC is a cancer of the prostate gland (a male reproductive gland found below the bladder) that has spread to other parts of the body. This type of prostate cancer does not respond to hormone treatment, which is used to lower the level of testosterone (male hormone), to prevent cancer from growing.
Radium-223 (Ra-223) has already been approved for the treatment of mCRPC. It is a type of radiation therapy that releases radiation after it is injected into the body, which can damage and slow down the growth of cancer cells.
The main purpose of this study is to learn more about the real-world use of Ra-223 in men with mCRPC in the United States.
To do this, researchers will collect the following information on:
• Number of participants who have completed six treatment cycles of Ra 223. A cycle is a treatment period that is repeated until the treatment is discontinued.
• Factors such as age, sex, and other treatment-related characteristics that can lead to stopping Ra-223 early
The data will come from the participants’ information stored in a database called Komodo Health (KH). Data collected will be from July 2017 to March 2022.
Researchers will only look at the health records from men with mCRPC in the United States.
Researchers will track participants’ data and will follow them for a maximum of 6 months or until the participant decides to leave the study, or the end of the study, or until they die.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
1376Trial Dates
September 2023 - May 2024Phase
N/ACould I Receive a placebo
N/AProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoTrial design
Trial Type
ObservationalIntervention Type
N/ATrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A