title: Multinational, double-blind, phase III study of prednisone and either satraplatin or placebo in patients with castrate-refractory prostate cancer progressing after prior chemotherapy: the SPARC trial.
abstract: OBJECTIVE
  This multinational, double-blind, randomized, placebo-controlled, phase III trial assessed the efficacy and tolerability of the oral platinum analog satraplatin in patients with metastatic castrate-refractory prostate cancer (CRPC) experiencing progression after one prior chemotherapy regimen.
  
  
  METHODS
  Nine hundred fifty patients were randomly assigned (2:1) to receive oral satraplatin (n = 635) 80 mg/m(2) on days 1 to 5 of a 35-day cycle and prednisone 5 mg twice daily or placebo (n = 315) and prednisone 5 mg twice daily. Primary end points were progression-free survival and overall survival (OS). The secondary end point was time to pain progression (TPP).
  
  
  RESULTS
  A 33% reduction (hazard ratio [HR] = 0.67; 95% CI, 0.57 to 0.77; P < .001) was observed in the risk of progression or death with satraplatin versus placebo. This effect was maintained irrespective of prior docetaxel treatment. No difference in OS was seen between the satraplatin and placebo arms (HR = 0.98; 95% CI, 0.84 to 1.15; P = .80). Compared with placebo, satraplatin significantly reduced TPP (HR = 0.64; 95% CI, 0.51 to 0.79; P < .001). Satraplatin was generally well tolerated, although myelosuppression and GI disorders occurred more frequently with satraplatin.
  
  
  CONCLUSIONS
  Oral satraplatin delayed progression of disease and pain in patients with metastatic CRPC experiencing progression after initial chemotherapy but did not provide a significant OS benefit. Satraplatin was generally well tolerated. These results suggest activity for satraplatin in patients with CRPC who experience progression after initial chemotherapy.
authors.affiliation: San Camillo and Forlanini Hospitals, Rome, Italy. cstern@mclink.it
authors.forename: Cora N
authors.initials: CN
authors.lastname: Sternberg
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Petrylak
authors.forename: Oliver
authors.initials: O
authors.lastname: Sartor
authors.forename: J Alfred
authors.initials: JA
authors.lastname: Witjes
authors.forename: Tomasz
authors.initials: T
authors.lastname: Demkow
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Ferrero
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Eymard
authors.forename: Silvia
authors.initials: S
authors.lastname: Falcon
authors.forename: Fabio
authors.initials: F
authors.lastname: Calabrò
authors.forename: Nicholas
authors.initials: N
authors.lastname: James
authors.forename: Istvan
authors.initials: I
authors.lastname: Bodrogi
authors.forename: Peter
authors.initials: P
authors.lastname: Harper
authors.forename: Manfred
authors.initials: M
authors.lastname: Wirth
authors.forename: William
authors.initials: W
authors.lastname: Berry
authors.forename: Michael E
authors.initials: ME
authors.lastname: Petrone
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: McKearn
authors.forename: Mojtaba
authors.initials: M
authors.lastname: Noursalehi
authors.forename: Martine
authors.initials: M
authors.lastname: George
authors.forename: Marcel
authors.initials: M
authors.lastname: Rozencweig
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003248:Constipation / Q000139:chemically induced; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009362:Neoplasm Metastasis; D009919:Orchiectomy; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; C081294:satraplatin; D011241:Prednisone