title: The New Combination Docetaxel, Prednisone and Curcumin in Patients with Castration-Resistant Prostate Cancer: A Pilot Phase II Study.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Oncology Department, Centre Jean Perrin, and University Clermont 1, UFR Mx00E9;decine, and Centre d'Investigation Clinique, Clermont-Ferrand, France.
authors.forename: Hakim
authors.initials: H
authors.lastname: Mahammedi
authors.forename: Eloise
authors.initials: E
authors.lastname: Planchat
authors.forename: Mélanie
authors.initials: M
authors.lastname: Pouget
authors.forename: Xavier
authors.initials: X
authors.lastname: Durando
authors.forename: Hervé
authors.initials: H
authors.lastname: Curé
authors.forename: Laurent
authors.initials: L
authors.lastname: Guy
authors.forename: Isabelle
authors.initials: I
authors.lastname: Van-Praagh
authors.forename: Laurent
authors.initials: L
authors.lastname: Savareux
authors.forename: Marc
authors.initials: M
authors.lastname: Atger
authors.forename: Mathilde
authors.initials: M
authors.lastname: Bayet-Robert
authors.forename: Emilie
authors.initials: E
authors.lastname: Gadea
authors.forename: Catherine
authors.initials: C
authors.lastname: Abrial
authors.forename: Emilie
authors.initials: E
authors.lastname: Thivat
authors.forename: Philippe
authors.initials: P
authors.lastname: Chollet
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Eymard
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D053379:Chromogranin A / Q000097:blood; D003474:Curcumin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010751:Phosphopyruvate Hydratase / Q000097:blood; D010865:Pilot Projects; D011241:Prednisone / Q000008:administration & dosage; D017430:Prostate-Specific Antigen / Q000097:blood; D064129:Prostatic Neoplasms, Castration-Resistant / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D053379:Chromogranin A; D043823:Taxoids; D000077143:Docetaxel; D017430:Prostate-Specific Antigen; D010751:Phosphopyruvate Hydratase; D003474:Curcumin; D011241:Prednisone