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

Castration-resistant Prostate Cancer Clinical Trial

— RAPIT  

Official title:

Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04232761
• Other study ID #: 21124
• Status: Active, not recruiting
• Start date: July 7, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 194
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
Drug administration as determined by treating physician

Locations

Country	Name	City	State
Taiwan	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)		Up to 7 months
Primary	Incidence of drug-related TEAEs		Up to 7 months
Primary	Descriptive analysis of long-term safety information during the extended follow-up period	This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.	Up to 2 years
Secondary	Overall survival		Up to 2 years
Secondary	Time to the first symptomatic skeletal event (SSE)		Up to 2 years
Secondary	Proportion of patients with total ALP (tALP) response	ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase	Up to 2 years
Secondary	Proportion of patients with PSA response	PSA - Prostate Specific Antigen	Up to 2 years
Secondary	Change in pain status	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)	Up to 2 years
Secondary	Change in ECOG-PS	The Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death).	Up to 2 years

External Links

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