Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Lenalidomide; Docetaxel; Prednisone; Placebo
Intervention description: 25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 intravenous docetaxel on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle; Oral placebo once each day on Days 1-14 of the treatment cycle
Intervention MeSH terms: Prednisone; Docetaxel; Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1059.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Castrate-Resistant Prostate Cancer; Revlimid; Lenalidomide

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          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

        Exclusion Criteria:

          1. A history of clinically significant disease that places subject at an unacceptable
             risk for study entry

          2. Prior Therapy with thalidomide, lenalidomide or pomalidomide

          3. Prior chemotherapy for prostate cancer

          4. Use of any other experimental drug or therapy within 28 days prior to randomization

          5. Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior
             to randomization

          6. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to
             randomization

          7. Surgery within 28 days prior to randomization

          8. Concurrent anti-androgen therapy

          9. Abnormal serum chemistry or hematology laboratory values

         10. Significant active cardiac disease within the previous 6 months:

         11. Thrombotic or thromboembolic events within the past 6 months:

         12. History of peripheral neuropathy of ≥grade 2

         13. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80

         14. Paraplegia

         15. History of Central nervous system (CNS) or brain metastases

         16. 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

         17. Concurrent use of alternative cancer therapies