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

摘要: Purpose This multinational, double-blind, randomized, placebo-controlled, phase III trial assessed the efficacy and tolerability of oral platinum analog satraplatin in patients with metastatic castrate-refractory prostate cancer (CRPC) experiencing progression after one prior chemotherapy regimen. Patients Methods Nine hundred fifty were randomly assigned (2:1) to receive (n = 635) 80 mg/m2 on days 1 5 a 35-day cycle prednisone mg twice daily or placebo 315) daily. Primary end points progression-free survival overall (OS). The secondary point was time pain (TPP). Results A 33% reduction (hazard ratio [HR] 0.67; 95% CI, 0.57 0.77; P < .001) observed risk death versus placebo. effect maintained irrespective docetaxel treatment. No difference OS seen between arms (HR 0.98; 0.84 1.1...