Multi-academic Center Study of Xofigo Patients

Completed

Conditions studied: Prostate Cancer, Castration Resistant

In brief

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.

Key facts

Study ID

NCT03419442

Run by

Bayer

People needed

150

Starts

2018-12-03

Expected to finish

2019-10-22

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Received at least one dose of radium-223 after mCRPC diagnosis
• Received at least one prescription or dose of chemotherapy for treatment of mCRPC

You may not qualify if…

• No documented visceral metastasis at initiation of radium-223

Where it is running

• Bayer US — Whippany, New Jersey, United States

Full record on ClinicalTrials.gov

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