drugset / Trial / NCT01809691
S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
Phase 3
Completed
1313 enrolled
SWOG Cancer Research Network
Millennium Pharmaceuticals, Inc. · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
Timeline
- Start
- 2013-03-08
- Primary completion
- 2022-03-08
- Completion
- 2025-09-09
Outcome
Missed primary endpoint
registry analysis (superiority test); LHRHa + TAK-700 vs LHRHa + Bicalutamide; p = .080; Hazard Ratio (HR) 0.86 (95% CI 0.72 to 1.02); Regression, Cox NCT01809691 ↗
paper CONCLUSION: The study did not meet the primary end point of improved OS with orteronel. PMID 35446628 ↗
Publications
- Gebrael G, Jo Y, Swami U, Plets M, Hage Chehade C, Narang A, Gupta S, Myint ZW, Sayegh N, Tangen CM, Hussain M, Dorff T, Lara PN Jr, Lerner SP, Thompson I, Agarwal N. Bone Pain and Survival Among Patients With Metastatic, Hormone-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG-1216 Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419966. doi: 10.1001/jamanetworkopen.2024.19966.
- Lara PN Jr, Mayerson E, Gertz E, Tangen C, Goldkorn A, van Loan M, Hussain M, Gupta S, Zhang J, Parikh M, Twardowski P, Quinn DI, LeBlanc M, Thompson I, Agarwal N. Markers of bone metabolism and overall survival in men with bone-metastatic hormone sensitive prostate cancer (HSPC): A subset analysis of SWOG S1216, a phase III trial of androgen deprivation with or without orteronel. Prostate Cancer Prostatic Dis. 2024 Sep;27(3):566-570. doi: 10.1038/s41391-024-00813-3. Epub 2024 Feb 29.
- Sayegh N, Swami U, Jo Y, Gebrael G, Haaland B, Gupta S, Plets M, Hussain MHA, Quinn DI, Lara PN Jr, Thompson IM Jr, Agarwal N. Race and Treatment Outcomes in Patients With Metastatic Castration-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG 1216 Phase 3 Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326546. doi: 10.1001/jamanetworkopen.2023.26546.
- Agarwal N, Tangen CM, Hussain MHA, Gupta S, Plets M, Lara PN, Harzstark AL, Twardowski PW, Paller CJ, Zylla D, Zibelman MR, Levine E, Roth BJ, Goldkorn A, Vaena DA, Kohli M, Crispino T, Vogelzang NJ, Thompson IM Jr, Quinn DI. Orteronel for Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Randomized, Open-Label Phase III Trial (SWOG-1216). J Clin Oncol. 2022 Oct 1;40(28):3301-3309. doi: 10.1200/JCO.21.02517. Epub 2022 Apr 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bicalutamide | Other / unclassified | 50 mg | Oral |
| Subject | Orteronel | Small molecule | 300 mg | Oral |