Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

Inclusion Criteria:

Must sign an Informed Consent Form (ICF)
Males ≥ 18 years of age
Able to adhere to the study visit schedule and requirements of the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Life expectancy of ≥ 12 weeks
Willingness to participate in Patient-Reported Outcomes assessments
Serum testosterone levels < 50 ng/dL
Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
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
Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
Refrain from donating blood or semen as defined by protocol

Exclusion Criteria:

A history of clinically significant disease that places subject at an unacceptable risk for study entry
Prior Therapy with thalidomide, lenalidomide or pomalidomide
Prior chemotherapy for prostate cancer
Use of any other experimental drug or therapy within 28 days prior to randomization
Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
Surgery within 28 days prior to randomization
Concurrent anti-androgen therapy
Abnormal serum chemistry or hematology laboratory values
Significant active cardiac disease within the previous 6 months:
Thrombotic or thromboembolic events within the past 6 months:
History of peripheral neuropathy of ≥grade 2
History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
Paraplegia
History of Central nervous system (CNS) or brain metastases
History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin
Concurrent use of alternative cancer therapies