Treating metastatic castration-resistant prostate cancer with novel polyamine-free oral nutritional supplementation: Phase I study

Abstract

BackgroundPolyamine (PA) dietary deprivation may be of clinical interest in castration-resistant prostate cancer (CRPC). PurposeWe assessed tolerance and side effects of PA-free oral nutritional supplement (ONS) combined with partial intermittent intestinal decontamination (PIID) in a Phase I trial. MethodsTen volunteers of mean age 68 ± 12 years and with symptomatic, metastatic CRPC were enrolled. PA-free ONS was given as the only food source three times daily during the first 2 weeks; twice daily with one PA-reduced meal for 3 weeks; and then once daily with two PA-reduced meals for 7 weeks. Oral neomycin was administered at 0.75 g/day as PIID every other week. Toxicity, performance, and pain status were rated on World Health Organization and European Organisation for Research and Treatment of Cancer scales. Prostate-specific antigen, blood counts, ionograms, and hepatic transaminases were regularly assessed. Bone and computed tomography scans were performed at weeks 0, 5 and 12. ResultsOne patient disliked the taste and stopped on Day 4. Nine patients experienced transient Grade I diarrhea. Performance status and pain score were significantly improved in five patients and maintained in three patients. No significant differences in body weight, hemoglobin, serum proteins, and ionograms were noted. Four patients had 20–40% prostate-specific antigen baseline decline during the first 5 weeks of the trial. Five patients had bone and computed tomography scan stabilization. ConclusionThis PA-free ONS was safe and well tolerated with PIDD. It seemed to benefit quality of life and control pain. The effects were dose dependent, with maximum improvement observed during the first 5 weeks when PA depletion was maximal.