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 (CRPC)
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Docetaxel
- drug : Prednisone
- drug : Lenalidomide
- drug : Placebo
Phase: Phase 3
Ages Eligible For Study:
1. Must sign an Informed Consent Form (ICF) 2. Males ? 18 years of age 3. Able to adhere to the study visit schedule and requirements of the protocol 4. Eastern Cooperative Oncology Group (ECOG) performance status of ? 2 5. Life expectancy of ? 12 weeks 6. Willingness to participate in Patient-Reported Outcomes assessments 7. Serum testosterone levels < 50 ng/dL 8. Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy 9. Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ?2 new bone lesions 10. Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide 11. Refrain from donating blood or semen as defined by protocol