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Completed

NCT Number: NCT04232761

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

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).

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Key information

Conditions

Castration-resistant Prostate Cancer

Sex eligibility

Male

Study type

Observational

Primary location

Many locations

Multiple Locations, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 dichloride (Xofigo, BAY88-8223)

Drug

Drug administration as determined by treating physician

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 7 months

  2. Incidence of drug-related TEAEs

    Time frame: Up to 7 months

  3. Descriptive analysis of long-term safety information during the extended follow-up period

    Time frame: Up to 2 years

    This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.

Secondary outcomes

  1. Overall survival

    Time frame: Up to 2 years

  2. Time to the first symptomatic skeletal event (SSE)

    Time frame: Up to 2 years

  3. Proportion of patients with total ALP (tALP) response

    Time frame: Up to 2 years

    ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase

  4. Proportion of patients with PSA response

    Time frame: Up to 2 years

    PSA - Prostate Specific Antigen

  5. Change in pain status

    Time frame: 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)

  6. Change in ECOG-PS

    Time frame: Up to 2 years

    The Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: RAPIT

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2020
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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