Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone

NCT ID: NCT04232761

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-07

Study Completion Date

2024-04-29

Brief Summary

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In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description

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The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan.

The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.

Conditions

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Castration-resistant Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CRPC patients

Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

Drug administration as determined by treating physician

Interventions

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Radium-223 dichloride (Xofigo, BAY88-8223)

Drug administration as determined by treating physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases
* Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator
* No contra-indications according to the local marketing authorization

Exclusion Criteria

* Previously treated with Radium-223 for any reason
* Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many locations

Multiple Locations, , Taiwan

Site Status

Countries

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Taiwan

Related Links

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https://clinicaltrials.bayer.com/

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Other Identifiers

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21124

Identifier Type: -

Identifier Source: org_study_id

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