Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).

CompletedOBSERVATIONAL
Enrollment

346

Participants

Timeline

Start Date

March 18, 2019

Primary Completion Date

June 8, 2020

Study Completion Date

December 14, 2020

Conditions
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Interventions
DRUG

Radium-223 (Xofigo, BAY88-8223)

Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

DRUG

Abiraterone

Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.

DRUG

Enzalutamide

Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.

Trial Locations (1)

07981

US Flatiron prostate cancer database, Whippany

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY