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)
Status
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Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Volunteers
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
Trial design
194 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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