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

Completed

• Conditions: Castration-resistant Prostate Cancer
• Interventions: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Registration Number: NCT04232761
• Lead Sponsor: Bayer

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-07-07
• Primary Completion: 2024-04-29
• Study Completion: 2024-04-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 194

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRPC patients	Radium-223 dichloride (Xofigo, BAY88-8223)	Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs)	Up to 7 months
Incidence of drug-related TEAEs	Up to 7 months
Descriptive analysis of long-term safety information during the extended follow-up period	Up to 2 years	This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with total ALP (tALP) response	Up to 2 years	ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase
Change in pain status	Up to 2 years	Pain status is assessed through analgesic utility that is calculated by WHO analgesic scores (0 - none, 1 - non-opioid, 2 - opioid for mild to moderate pain, 3 - opioid for moderate to severe pain)
Overall survival	Up to 2 years
Time to the first symptomatic skeletal event (SSE)	Up to 2 years
Proportion of patients with PSA response	Up to 2 years	PSA - Prostate Specific Antigen
Change in ECOG-PS	Up to 2 years	The Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death).

Trial Locations

Locations (1)

Many locations; 🇨🇳 Multiple Locations, Taiwan