Originally published as JCO Early Release 10.1200/JCO.2008.20.1228 on October 5 2009

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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

From the From San Camillo and Forlanini Hospitals, Rome, Italy; Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands; Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii–Instytut, Warsaw, Poland; Centre Antoine Lacassagne, Nice; Institut Jean Godinot, Reims, France; Hospital E. Rebagliati-EsSalud, Lima, Peru; Cancer Research UK Institute for Cancer Studies, Birmingham; Guy's Hospital, London, United Kingdom; National Institute of Oncology, Budapest, Hungary; Universitätsklinikum der Carl-Gustav-Carus Universität, Dresden, Germany; Columbia University, New York, NY; Tulane Medical School, New Orleans, LA; Raleigh Hematology Oncology Clinic, Raleigh, NC; and GPC Biotech, Princeton, NJ.

Corresponding author: Cora N. Sternberg, MD, Department of Medical Oncology, San Camillo and Forlanini Hospitals, Nuovi Padiglioni, 4th Floor, Circonvallazione Gianicolense 87, IT-00152, Rome, Italy; e-mail: cstern{at}mclink.it.

Purpose 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.

Patients and Methods Nine hundred fifty patients were randomly assigned (2:1) to receive oral satraplatin (n = 635) 80 mg/m² 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.

Conclusion 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.

Written on behalf of the Satraplatin and Prednisone Against Refractory Cancer (SPARC) study group.

Supported by GPC Biotech, Princeton, NJ, and Celgene, Summit, NJ.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00069745 [ClinicalTrials.gov] .

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