NCT03325127

Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study

Outcomes and Treatment Patterns of Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223 Concomitantly With Abiraterone or Enzalutamide in First Line Setting : A Retrospective Chart Abstraction Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.

Conditions

• Prostatic Neoplasms, Castration-Resistant

Interventions

Type	Name	Description
DRUG	radium Ra 223 dichloride (Xofigo, BAY88-8223)	Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections
DRUG	Zytiga	Abiraterone 1000 mg per day orally
DRUG	Xtandi	Enzalutamide 160 mg per day orally

Timeline

• Start date: 2017-10-30
• Primary completion: 2018-09-28
• Completion: 2018-09-28
• First posted: 2017-10-30
• Last updated: 2018-10-31