Clinical trial · Interventional
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Docetaxel, Prednisone, Lenalidomide (DPL)
- description
- 25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle
- interventionNames
- Drug: Lenalidomide
- Drug: Docetaxel
- Drug: Prednisone
- type
- EXPERIMENTAL
- label
- Docetaxel and Prednisone (DP)
- description
- Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle
- interventionNames
- Drug: Docetaxel
- Drug: Prednisone
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDVogelzang NJ, Fizazi K, Burke JM, De Wit R, Bellmunt J, Hutson TE, Crane E, Berry WR, Doner K, Hainsworth JD, Wiechno PJ, Liu K, Waldman MF, Gandhi A, Barton D, Jungnelius U, Fandi A, Sternberg CN, Petrylak DP. Circulating Tumor Cells in a Phase 3 Study of Docetaxel and Prednisone with or without Lenalidomide in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Feb;71(2):168-171. doi: 10.1016/j.eururo.2016.07.051. Epub 2016 Aug 10. PMID 27522164
- RESULTPetrylak DP, Vogelzang NJ, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, de Olza MO, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, Van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, de Wit R, Fizazi K. Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2015 Apr;16(4):417-25. doi: 10.1016/S1470-2045(15)70025-2. Epub 2015 Mar 3. PMID 25743937
- RESULTde Morree ES, Vogelzang NJ, Petrylak DP, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, Ochoa de Olza M, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, Li JS, de Wit R. Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study. JAMA Oncol. 2017 Jan 1;3(1):68-75. doi: 10.1001/jamaoncol.2016.3000. PMID 27560549