Cabozantinib Versus Mitoxantrone-prednisone in Symptomatic Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial with a Primary Pain Endpoint.

ABSTRACT:

Background

Bone metastases in patients with metastatic castration-resistant prostate cancer (mCRPC) are associated with debilitating pain and functional compromise.

Objective

To compare pain palliation as the primary endpoint for cabozantinib versus mitoxantrone-prednisone in men with mCRPC and symptomatic bone metastases using patient-reported outcome measures.

Design, setting, and participants

A randomized, double-blind phase 3 trial (COMET-2; NCT01522443) in men with mCRPC and narcotic-dependent pain from bone metastases who had progressed after treatment with docetaxel and either abiraterone or enzalutamide.

Intervention

Cabozantinib 60mg once daily orally versus mitoxantrone 12mg/m² every 3wk plus prednisone 5mg twice daily orally.

Outcome me

SUBMITTER: Basch EM 

PROVIDER: S-EPMC6876845 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature