Phase 3
Completed N=1,059
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Source: ClinicalTrials.gov NCT00988208 ↗Enrolled (actual)
1,059
Serious AEs
43.9%
Results posted
Sep 2013
Primary outcomePrimary: Overall Survival (OS) — NA; 77 weeks — p=0.0017
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
NA; 77 | 0.0017 sig |
| SECONDARY Progression-Free Survival (PFS) |
46; 45 | 0.0187 sig |
| SECONDARY Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria |
24.3; 22.1 | 0.3975 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) |
512; 517; 379; 412; 475; 481 | — |
| SECONDARY Percentage of Participants Who Received Post-Study Therapies |
70.8; 69.0 | — |
| SECONDARY Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial |
1.3; 1.7; 0.4; 1.0 | — |
| SECONDARY Time to Onset of Secondary Primary Malignancies |
29.7; 19.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00988208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.