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

NCT04232761 | Completed

• 1 other identifier: 21124
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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).

Conditions

Castration-resistant Prostate Cancer

Keywords

Bone metastases; Radium-223 dichloride

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

  Up to 2 years

• Proportion of patients with PSA response

  Up to 2 years

• Change in pain status

  Up to 2 years

Study Arms (1)

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)

Interventions

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

Drug administration as determined by treating physician

CRPC patients

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients in routine clinical practice from Taiwan

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Taiwan

Location

Related 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.

MeSH Terms

Interventions

radium Ra 223 dichloride

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: July 7, 2020
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)