NCT03419442

Multi-academic Center Study of Xofigo Patients

A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide. The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.

Conditions

• Prostate Cancer, Castration Resistant

Interventions

Type	Name	Description
DRUG	Xofigo	Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
DRUG	Taxotere	Docetaxel injection 75mg/m2 every 3 weeks
DRUG	Jevtana	Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-10-22
• Completion: 2019-10-22
• First posted: 2018-02-05
• Last updated: 2020-10-22

Locations

1 site across 1 country: United States