check_circleStudy Completed

Metastatic castration resistant prostate cancer (mCRPC)

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A

Trial summary

Enrollment Goal
1376
Trial Dates
September 2023 - May 2024
Phase
N/A
Could I Receive a placebo
N/A
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Trial design

Radium-223 Utilization Patterns among Commercially Insured, and Medicare Advantage Beneficiaries with Prostate Cancer in the United States
Trial Type
Observational
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A