Favorable phase I results justified this pilot phase II study to assess the efficacy of docetaxel/curcumin in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (CRPC).
Thirty patients with progressing CRPC and a rising prostate-specific antigen (PSA) received docetaxel/prednisone in standard conditions for 6 cycles in combination with per os curcumin, 6,000 mg/day (day -4 to day +2 of docetaxel). The co-primary endpoint was the overall response rate determined by PSA and target assessments. An ancillary study assessed the seric values of chromogranin A (CgA) and neuron-specific enolase (NSE).
Twenty-six patients received the scheduled treatment, 2 progressed and 2 died before the end of treatment. A PSA response was observed in 59% of patients (14% of PSA normalization) and achieved within the first three cycles for 88% of responders. Partial response was reached for 40% of evaluable patients. The regimen was well tolerated, and no adverse event was attributed to curcumin. Twenty patients were 100% curcumin compliant. The PSA level and objective response rate were not correlated with the serum values of CgA and NSE.
This study produced additional data on curcumin as a treatment for cancer, with a high response rate, good tolerability and patient acceptability, justifying the interest to conduct a randomized trial.
Oncology. 2016 Jan 16 [Epub ahead of print]
Hakim Mahammedi, Eloise Planchat, Mélanie Pouget, Xavier Durando, Hervé Curé, Laurent Guy, Isabelle Van-Praagh, Laurent Savareux, Marc Atger, Mathilde Bayet-Robert, Emilie Gadea, Catherine Abrial, Emilie Thivat, Philippe Chollet, Jean-Christophe Eymard
Oncology Department, Centre Jean Perrin, and University Clermont 1, UFR Mx00E9;decine, and Centre d'Investigation Clinique, Clermont-Ferrand, France.