A clinical trial demonstrated that treatment with oral multikinase regorafenib improved overall survival (OS), progression-free survival (PFS), and disease control [García-Alfonso et al.: J Clin Transl Oncol 2016;18:1072-1081; Bertocchi et al.: J Chemother 2017;29:102-105]. In this study, we aimed to evaluate its effectiveness in Italian patients with hormone-refractory metastatic castration-resistant prostate cancer (mCRPC) progressing after chemotherapy with docetaxel plus prednisone.

60 patients were enrolled. OS has been assessed as the primary endpoint while PFS, quality of life, safety, and response rate represented secondary endpoints.

A modest tolerability was observed in our group showing a manageable toxicity profile and a modest objective response rate. It was associated with stable disease. A significant correlation between quality of life and OS was also noticed.

Regorafenib has been proven to be an effective and well-tolerated therapeutic option in patients with mCRPC progressing after docetaxel plus prednisone treatment.