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.
Study Type
OBSERVATIONAL
Enrollment
150
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
Docetaxel injection 75mg/m2 every 3 weeks
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
Bayer US
Whippany, New Jersey, United States
Overall survival
Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).
Time frame: Up to 30 months
Time to symtomatic skeletal event(SSE)
Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
Time frame: Up to 30 months
Reasons for treatment discontinuation
data for treatment discontinuation for each mCRPC therapy will be collected
Time frame: Up to 30 months
Laboratory-based outcomes collected by questionnaire
Data will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxel
Time frame: Up to 30 months
Treatments received
measured as Yes/No
Time frame: Up to 30 months
Number of hospitalizations
along with the discharge diagnosis, as recorded in medical charts or discharge summaries
Time frame: Up to 30 months
PSA PFS
defined as death or an increase above PSA nadir by ≥25% and ≥2 ng/mL (PCWG 2008 definition for Prostate specific antigen(PSA) Progression-free survival(PFS))
Time frame: Up to 30 months
Non-laboratory based clinically relevant safety outcomes
documented in medical records
Time frame: Up to 30 months
hospital length of stay
Time frame: Up to 30 months
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