The evaluation of lenalidomide, with or without Docetaxel plusPrednisone, in the treatment of prostate cancer, when the cancer does not respond to hormonal treatment

Phase 1

Conditions: Chemo-naïve metastatic prostate cancer subjects with documented rising Prostate Specific Antigen (PSA) or documented Progressive Disease (PD) following hormonal therapy
MedDRA version: 17.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2008-007969-23-HU

Lead Sponsor: Celgene Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 1059

Inclusion Criteria

Screening and recruitment was completed under protocol amendment 2

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 317
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 742

Exclusion Criteria

Screening and recruitment was completed under protocol amendment 2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To continue to collect information on Second Primary Malignancies (SPMs) and additional <br>treatments for prostate cancer in all randomized subjects during survival follow-up<br>- To continue to provide docetaxel and prednisone to CRPC subjects randomized at non-US <br>sites who were ongoing in the CC-5013-PC-002 (Amendment 2, Version dated 09-Jun-<br>2011) protocol when the decision was made to discontinue lenalidomide/placebo and are <br>experiencing benefit as per investigator discretion ;Secondary Objective: N/A;Primary end point(s): Data on Second Primary Malignancies and additional treatments for prostate cancer;Timepoint(s) of evaluation of this end point: Subjects will be followed for SPM every 90 days after treatment phase discontinuation for up to 5 years or until all subjects have died

Secondary Outcome Measures