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

Sternberg, Cora N.; Petrylak, Daniel P.; Sartor, Oliver; Witjes, J. Alfred; Demkow, Tomasz; Ferrero, Jean Marc; Eymard, Jean Christophe; Falcon, S.; Calabrò, Fabio; James, Nicholas D.; Bodrogi, I.; Harper, Peter; Wirth, Manfred; Berry, William A.; Petrone, Michael E.; McKearn, Thomas J.; Noursalehi, Mojtaba; George, Mercy; Rozencweig, Marcel

doi:10.1200/jco.2008.20.1228

Cited by 312 publications

(171 citation statements)

References 28 publications

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“…The conundrum of PFS and survival being delinked is now becoming a familiar story in mCRPC. In a large randomized phase III trial, satraplatin/ prednisone had a PFS but not OS advantage over prednisone alone [5]. Similar findings with regard to PFS and OS were reported for bevacizumab/docetaxel/prednisone as compared to docetaxel/prednisone [6].…”

supporting

confidence: 64%

Twists and turns on the way to progress in metastatic castrate-resistant prostate cancer

Sartor

2010

Asian J Androl

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supporting

confidence: 64%

Twists and turns on the way to progress in metastatic castrate-resistant prostate cancer

Sartor

2010

Asian J Androl

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“…Progression-free survival has been shown to be predictive of OS in men with CRPC [19] although the association between progression-free survival and OS is relatively weak. Some reports indicate improvement in OS without an increase in progressionfree survival [9] or improvement in progression-free survival without an increase in survival [20]. Accurate prediction models for prostate cancer survival probability would be valuable for patient counseling and useful for considering the early use of cytotoxic therapy.…”

Section: Discussionmentioning

confidence: 99%

Nomogram for Overall Survival of Japanese Patients with Bone Metastatic Prostate Cancer

Miyoshi¹,

Noguchi²,

Yanagisawa³

et al. 2014

Med Surg Urol

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Objective: We analyzed the relationship between prostate cancer outcome and pretreatment clinical factors, and developed a prognostic nomogram for Overall Survival (OS) of patients with bone metastasis. Methods:Beginning in 1993 to 2011, 463 consecutive prostate cancer patients with bone metastasis were treated. Data sets from 361 patients were used to develop the nomogram (training data), and data sets of 102 patients were used for validation of the nomogram (validation data). Using the external validation data set, the nomogram was assessed for discriminatory ability, and the predictions were assessed for calibration accuracy by plotting actual survival against predicted risk.Results: Of 361 training data set, 205 (56.8%) patients died, 169 (46.8%) deaths of which were due to prostate cancer. The Median follow-up of patients were 55.2 months. In multivariate analysis, patient age, serum PSA, clinical T stage, extent of disease on bone scan (EOD), and biopsy Gleason sum were independent prognostic factors. We developed a prognostic model for prostate cancer patients with bone metastasis, consisting of these five factors. This nomogram can be used to estimate 1-, 3-, and 5-year survival probability. External validation of this model using 102 validation data sets showed reasonable accuracy (c-index 0.719), although with slight underestimation. Conclusion:Our pretreatment prognostic nomogram might be useful for Japanese prostate cancer patients with bone metastasis.

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“…Results from a prematurely terminated, randomized, phase III trial combining satraplatin with prednisone as first-line therapy for CRPC suggested that it has promising antitumor activity compared with prednisone alone (32), and this led to a randomized, placebo-controlled, phase III trial of this regimen as second-line therapy. The Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial enrolled 950 patients unresponsive to prior chemotherapy (51% had received prior docetaxel): patients were randomized to receive satraplatin (80 mg/m 2 x 5 days, q5 weeks) plus prednisone or prednisone plus placebo (34). The primary endpoint was PFS, defined by radiological progression, symptomatic progression (i.e.…”

Section: Agents Under Developmentmentioning

confidence: 99%

Novel strategies in the treatment of castration-resistant prostate cancer (Review)

et al. 2012

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Abstract. Prostate cancer is the most common cancer in men in Europe and the United States, and the third leading cause of death from cancer in Europe. Survival of prostate cancer cells is dependent on the activation of androgen receptors (AR), that are overexpressed in this tumor. Furthermore, ~90% of prostate cancer patients that respond to first-line androgen deprivation therapy (ADT) undergo rapid progression. This condition is defined as castration-resistant prostate cancer (CRPC). Docetaxelbased regimens significantly improve overall survival (OS) in patients with CRPC and represent the only treatment strategy approved by the Food and Drug Administration (FDA). Recently, abiraterone (second hormonal therapy) and cabazitaxel (new taxane) have been shown to improve survival in patients with CRPC who progressed following docetaxel-based chemotherapy. Vaccine therapy has also been demonstrated to improve OS in patients with asymptomatic or minimally symptomatic metastatic CRPC. Additional therapeutic targets have been analyzed in prostate cancer, including apoptosis, angiogenic receptors, vitamin D and Src pathways. Several phase II studies are ongoing. The high frequency of prostate cancer-related metastatic bone disease has led to consider this pathway as a therapeutic target. To this end, several bone-targeted agents have been investigated, most notably zoledronic acid, which is highly effective at stabilizing the bone and preventing skeletal complications. More recently, a nuclear factor-β ligand (RANKL) inhibitor, denosumab, has been developed for the treatment of bone metastases.

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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

Cited by 312 publications

References 28 publications

Twists and turns on the way to progress in metastatic castrate-resistant prostate cancer

Twists and turns on the way to progress in metastatic castrate-resistant prostate cancer

Nomogram for Overall Survival of Japanese Patients with Bone Metastatic Prostate Cancer

Novel strategies in the treatment of castration-resistant prostate cancer (Review)

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