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Prostate

A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone with or without Lenalidomide in Subjects with Castrate-Resistant Prostate Cancer

Unique Data Set IDProstat_Celgene_2009_90
DownloadableYes
SponsorCelgene CorporationData ProviderCelgeneTotal Study Enrolled Patients1059Comparator (Control) Arm Enrolled Patients526RandomizationYesClinicalTrial.gov IDNCT00988208ClinicalTrial.gov URLhttp://clinicaltrials.gov/ct2/show/NCT00988208?term=Lenalidomide+Prostate+Cancer&rank=5
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, Placebo, DrugData Set TypeSDTM

Clinical Trial Title

A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone with or without Lenalidomide in Subjects with Castrate-Resistant Prostate Cancer

Trial Summary and Conditions

This dataset was part of the training data curated for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/149

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 is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study in chemo-naive subjects with metastatic castrate-resistant prostate cancer (CRPC) with documented progressive disease as determined by rising PSA levels or radiological progression following hormone therapy. Subjects meeting the exclusion criteria will be randomized 1:1 into one of two treatment arms: -DP Treatment Arm: docetaxel, prednisone, and placebo -DPL Treatment Arm: docetaxel, prednisone, and lenalidomide Note: For purposes of this study, PSA progression is not considered disease progression and does not mandate discontinuation from the Treatment Phase of the study. Subjects experiencing treatment related-toxicity will be allowed to dose reduce or discontinue either docetaxel or lenalidomide while remaining eligible to continue study treatment with the remaining drug. Complete discontinuation of both drugs will result in discontinuation of study treatment. All subjects will be contacted 28 days after the last dose for adverse events (AEs) and concomitant medications and then followed for survival and post-study prostate cancer treatments every 90 days until death or up to 5 years following treatment phase discontinuation. Efficacy and safety assessments to be performed during the study are detailed in Protocol Table 2: Schedule of Study Assessments.

Data Summary

This de-identified data set represents 529 patients enrolled from an FDA approved comparator DP Treatment Arm: docetaxel, prednisone, and placebo. A total of 1059 patients were accrued to the study globally.

Study Objectives

Primary: To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line therapy in chemo-naive metastatic CRPC subjects Secondary -Progression-Free Survival (PFS) -Objective Response Rate -Safety of lenalidomide in combination with docetaxel and prednisone Exploratory -PSA response, PSA progression, PSA doubling time and PSA velocity -Biomarker analysis -Pharmacokinetic analysis -Change in Analgesic Use -Patient-Reported Outcomes

Outcome Measures

Change in Analgesic Use will be evaluated over the course of the study for the interpretation of self-reported pain severity in light of concomitant analgesic use. Patient-Reported Outcomes (PRO) will be performed using the validated instruments listed below for Pain and Health-Related Quality of Life (HRQoL) assessments: -Pain Assessment -Brief Pain Inventory-Short Form (BPI-SF) -Health-Related Quality of Life and Prostate Cancer Symptoms -Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) -EuroQol (EQ-5D) Questionnaire

Available Downloads:

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

PROTOCOL: CC-5013-PC-002 Final Protocol_Redacted.pdf

CRF: blankCRF_RedactedMAINSAIL.pdf

DATA (COMPARATOR ARM): PC002_De-id_Database 2.zip