A Study to Learn More About How Radium-223 Affects the Quality of Life of Colombian Patients With Prostate Cancer That Has Not Responded to Testosterone Lowering Treatment and Has Spread to the Bones, and to Better Understand Its Safety

NCT ID: NCT04681144

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2022-11-21

Brief Summary

The study drug, radium-223, gives off radiation that helps to kill cancer cells in the prostate. It is already available for patients to receive as a treatment for prostate cancer that has not responded to testosterone lowering treatment and has spread to the bones. This type of cancer is called metastatic castration-resistant prostate cancer, also called mCRPC. Sometimes, researchers continue studying an available treatment to learn more about how it affects patients' daily lives.

In this study, the researchers want to learn more about how radium-223 affects the patients' ability to do their daily tasks. The patients in this study will already be receiving treatment with radium-223 as part of their routine care. The tests and measurements in this study will be done by the patients' own doctors. The researchers will collect information about the patients' treatment and results.

The study will include patients with mCRPC who have at least 2 tumors in their bones. These patients will have recently started treatment with radium-223. The patients will have also had surgery or treatment to lower their testosterone levels. But, the treatment did not help their cancer. The study will include about 105 men in Colombia who are at least 18 years old.

All of the patients will receive radium-223 through a needle put into the vein, also called an intravenous injection. They will visit their doctor's office up to 8 times during 28 weeks. At these visits, their doctors will ask how they are feeling and what medications they are taking, and will take blood samples. The doctors will also give the patients surveys about their physical, social, and emotional health and about the symptoms of their prostate cancer.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Radium-223-dichloride (Xofigo, BAY88-8223)

Patients with metastatic castration-resistant prostate cancer (mCRPC)

Radium-223-dichloride (Xofigo, BAY88-8223)

Intervention Type: DRUG

Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice

Interventions

Radium-223-dichloride (Xofigo, BAY88-8223)

Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male adult patients (> 18 years)
• Label Xofigo
• Signed informed consent
• No participation in an investigational program with interventions outside of routine clinical practice.
• Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice, as treatment option for mCRPC either as first line (naïve), second line (after progression during treatment with enzalutamide or abiraterone) or third line (post-Docetaxel).

Exclusion Criteria

• Patients with contraindications to the use of Radium-223 according to the local label.
• Patients and who refused to sign the informed consent form.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many Locations

Multiple Locations, , Colombia

Countries

Colombia

Related Links

https://clinicaltrials.bayer.com/

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Other Identifiers

21517

Identifier Type: -

Identifier Source: org_study_id