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Prostate

A multicenter, randomized, double-blind, phase 3 study of sunitinib plus prednisone versus prednisone in patients with progressive metastatic castration-resistant prostate cancer after failure of a docetaxel-based chemotherapy regimen

Unique Data Set IDProstat_Pfizer_2008_81
DownloadableYes
SponsorPfizerData ProviderPfizerTotal Study Enrolled Patients873Comparator (Control) Arm Enrolled Patients285RandomizationYesClinicalTrial.gov IDNCT00676650ClinicalTrial.gov URLhttp://clinicaltrials.gov/ct2/show/NCT00676650?term=NCT00676650&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypePlaceboData Set TypeSDTM

Clinical Trial Title

A multicenter, randomized, double-blind, phase 3 study of sunitinib plus prednisone versus prednisone in patients with progressive metastatic castration-resistant prostate cancer after failure of a docetaxel-based chemotherapy regimen

Trial Summary and Conditions

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

This was a randomized (2:1), multicenter, double-blind, placebo-controlled, Phase 3 clinical trial evaluating the efficacy and safety of sunitinib + prednisone (SP) versus placebo+prednisone (PP) in subjects with CRPC whose disease failed treatment with a docetaxel-based chemotherapy regimen.

Data Summary

The study did not meet its primary endpoint of improvement in overall survival. The study was prematurely discontinued due to futility at an interim analysis.

Study Objectives

To demonstrate superiority in the Overall Survival (OS) of subjects with progressive CRPC treated with sunitinib plus prednisone (SP) versus placebo plus prednisone (PP) after failure of a docetaxel-based chemotherapy regimen. Secondary Objectives: To demonstrate superiority in the Progression Free Survival (PFS) of subjects with progressive CRPC treated with SP versus PP after failure of a docetaxel-based chemotherapy regimen. To compare the Overall Response Rate (ORR) and duration of response (DR) in subjects with progressive castration-resistant prostate cancer (CRPC) treated with SP versus PP after failure of a docetaxel-based chemotherapy regimen. To compare patient-reported outcomes (PROs) of pain severity, health-related quality of life, prostate cancer-specific symptoms, and general health status in subjects with progressive CRPC treated with SP versus PP after failure of a docetaxel-based chemotherapy regimen. To evaluate the safety and tolerability of sunitinib in combination with prednisone.

Outcome Measures

Overall survival, progression-free survival, response rate, adverse events.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Pfizer Study Protocol Sunitinib.pdf

CRF: Pfizer CRF Sunitinib.pdf

DATA DICTIONARY: Pfizer Data Descriptors Sunitinib.xlsx

DATA (COMPARATOR ARM): Pfizer Data Sunitinib.zip