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 (RAPIT)

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

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).

Study Overview

• Status: Completed
• Conditions: Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

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.

• Study Type: Observational
• Enrollment (Actual): 194

Contacts and Locations

Study Locations

• Taiwan
  • Multiple Locations, Taiwan
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients in routine clinical practice from Taiwan

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug administration as determined by treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		Up to 2 years
Time to the first symptomatic skeletal event (SSE)		Up to 2 years
Proportion of patients with total ALP (tALP) response	ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase	Up to 2 years
Proportion of patients with PSA response	PSA - Prostate Specific Antigen	Up to 2 years
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
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): April 29, 2024
• Study Completion (Actual): April 29, 2024

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Bone metastases; Radium-223 dichloride
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 21124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No