PROSPER: a phase III trial of lecithinized superoxide dismutase to prevent oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.

Background: Oxaliplatin-based chemotherapy is a standard adjuvant therapy for stage II or stage III colorectal cancer (CRC); however, its use is limited by chemotherapy-induced peripheral neuropathy (CIPN), which reduces the quality of life of patients and often persists for months or years after chemotherapy ends. Compared with superoxide dismutase (SOD), lecithinized SOD (PC-SOD) exhibits much longer stability in plasma, thus reducing oxidative stress, which is a key mechanism of CIPN. A randomized phase II trial (jRCT2031210466) of PC-SOD compared with placebo in patients with CRC who received adjuvant mFOLFOX6 therapy showed promising results regarding its CIPN-preventive effect and safety. Furthermore, PC-SOD suppressed oxaliplatin allergy. Design: PROSPER (Pc-sod for the pRevention Of Sensory PERipheral neuropathy) is a multicenter, randomized, double-blind, placebo-controlled, phase III study designed to investigate the efficacy of PC-SOD for CIPN in patients with CRC who receive adjuvant mFOLFOX6 therapy. Key eligibility criteria include curative resection of stage II or stage III colorectal adenocarcinoma and 12 planned cycles of mFOLFOX6. The primary endpoint is the time to onset of grade ≥2 CIPN (Common Terminology Criteria for Adverse Events). Key secondary endpoints include the time to onset of grade ≥2 CIPN (Neurotoxicity Criteria of Debiopharm) and oxaliplatin allergy.