Clinical trial 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
Official title: Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Castration-resistant Prostate Cancer
Keywords: Bone metastases
Radium-223 dichloride
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 194
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients in routine clinical practice from Taiwan

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 7 months
measure: Incidence of drug-related TEAEs
timeFrame: Up to 7 months
measure: Descriptive analysis of long-term safety information during the extended follow-up period
timeFrame: Up to 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 2 years
measure: Time to the first symptomatic skeletal event (SSE)
timeFrame: Up to 2 years
measure: Proportion of patients with total ALP (tALP) response
timeFrame: Up to 2 years
measure: Proportion of patients with PSA response
timeFrame: Up to 2 years
measure: Change in pain status
timeFrame: Up to 2 years
measure: Change in ECOG-PS
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Multiple Locations
country: Taiwan
facility: Many locations
Study officials:
References: