Real world evaluation of access-driven Canadian treatment sequences in progressive prostate cancer

Summary

Client: Bayer Inc.

Project ID: P2018-053 / 2020 0970 192 000

Research Question/Objectives: Approximately 90% of prostate cancer patients who progress to metastatic castration resistant prostate cancer (mCRPC) will develop bone metastases that cause skeletal related events (SREs) e.g. spinal cord compression and fractures and their related treatments. This SRE results in decreased quality of life (QoL) as well as increased healthcare resource utilization (e.g. opiate use, emergency department visits, hospitalizations) throughout their disease journey. Radium-223 is a first-in-class targeted alpha therapy with a significant, clinically meaningful overall survival benefit.

Specifically, the research objectives of interest are:

• Evaluate the relative merit of the placement of Ra-223 in the treatment sequence on overall survival.
• Evaluate the relative merit of the placement of Ra-223 in the treatment sequence on other composite efficacy endpoints like progression free survival (PFS) and symptomatic skeletal event-free survival (SSE-FS).
• Evaluate the relative merit of the placement of Ra-223 in the treatment sequence on the prevalence and time to event data of different safety endpoints (e.g. fracture, hospitalization).
• Evaluate the predictive value of the changes in biochemical markers on survival or progression outcomes.
• Describe the real-world resource utilization based on the placement of Ra-223 in the treatment sequence by disease phase.

Results:

• Dataset creation plan
• Final deliverable