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Prostate

A multicenter phase III randomized trial comparing TAXOTERE administered either weekly or every three weeks in combination with prednisone versus mitoxantrone in combination with prednisone for metastatic hormone-refractory prostate cancer

Unique Data Set IDProstat_Sanofi_2000_80
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients1006Comparator (Control) Arm Enrolled Patients337RandomizationYesClinicalTrial.gov IDN/AClinicalTrial.gov URLN/A
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeADS

Clinical Trial Title

A multicenter phase III randomized trial comparing TAXOTERE administered either weekly or every three weeks in combination with prednisone versus mitoxantrone in combination with prednisone for metastatic hormone-refractory prostate cancer

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

Promising results have been reported with Docetaxel in Hormone Refractory Prostate Cancer (HRPC) in terms of i) objective response in measurable lesions, ii) palliative response (pain relief, analgesic intake, symptom control), iii) PSA decline of more than 50%. These results which compared favorably with data from other cytotoxic combinations reported thus far should now be confirmed and further prospectively investigated through a multicenter randomized phase III trial.

Data Summary

These datasets are analysis datasets that bear some resemblance to CDISC ADaM standards. These datasets has been subsetted to include data for only the comparator arm of this clinical trial.

Study Objectives

PRIMARY OBJECTIVE To compare overall survival (OS) after mitoxantrone and prednisone (arm A) and docetaxel and prednisone (with arm B: docetaxel Every 3 weeks and with arm C: weekly docetaxel) in subjects with metastatic hormone-refractory prostate cancer. SECONDARY OBJECTIVES • Pain Progression-Free Survival • PSA Progression-Free Survival • Tumor Progression-Free Survival • Disease Progression-Free Survival • Pain improvement (incidence and duration) • PSA response (incidence and duration) • Quality of life • Response rate in subjects with measurable disease • Safety • Pharmacokinetics of Taxotere in combination with prednisone An independent socio-economic evaluation was to be conducted in parallel with the clinical study.

Outcome Measures

Outcomes documented in the protocol

Available Downloads:

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

PROTOCOL: Sanofi Study Protocol Taxotere.pdf

CRF: Sanofi CRF Taxotere.pdf

DATA (COMPARATOR ARM): Sanofi Data Descriptors Taxotere.doc

DATA (COMPARATOR ARM): Sanofi Data Taxotere.zip