title: A Randomised Phase II Trial Comparing Docetaxel Plus Prednisone with Docetaxel Plus Prednisone Plus Low-Dose Cyclophosphamide in Castration-Resistant Prostate Cancer.
abstract: BACKGROUND
  Docetaxel plus prednisone is a standard treatment for castration-resistant prostate cancer. Cyclophosphamide may be an effective combination partner.
  
  
  METHODS
  This randomised, multicentre, phase II trial compared the combination therapy of docetaxel plus prednisone plus cyclophosphamide with the standard therapy of docetaxel plus prednisone.
  
  
  RESULTS
  Thirty-three patients received six 3-week treatment cycles (in total 171 cycles). During treatment, an adequate decline in prostate-specific antigen was seen in both groups (p = 0.068) without between-group differences (p = 0.683). No relevant differences between within-group changes were observed for blood pressure, weight, pain score, laboratory variables or quality of life. There were no serious side effects apart from leucopenia requiring treatment (docetaxel + prednisone + cyclophosphamide arm) and no drug-related withdrawals; all three fatalities were considered to be cancer related.
  
  
  CONCLUSIONS
  The oncological effectiveness and tolerability of docetaxel plus prednisone were supported; an additional effect of cyclophosphamide was not detected. However, the small number of patients and short observation period restrict the generalisability of the results.
authors.forename: Markus
authors.initials: M
authors.lastname: Porsch
authors.forename: Matthias
authors.initials: M
authors.lastname: Ulrich
authors.forename: Johann Jakob
authors.initials: JJ
authors.lastname: Wendler
authors.forename: Uwe-Bernd
authors.initials: UB
authors.lastname: Liehr
authors.forename: Frank
authors.initials: F
authors.lastname: Reiher
authors.forename: Andreas
authors.initials: A
authors.lastname: Janitzky
authors.forename: Daniel
authors.initials: D
authors.lastname: Baumunk
authors.forename: Daniel
authors.initials: D
authors.lastname: Schindele
authors.forename: Florian
authors.initials: F
authors.lastname: Seseke
authors.forename: Anke
authors.initials: A
authors.lastname: Lux
authors.forename: Martin
authors.initials: M
authors.lastname: Schostak
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D064129:Prostatic Neoplasms, Castration-Resistant / Q000175:diagnosis* / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D003520:Cyclophosphamide; D011241:Prednisone