drugset / Trial / NCT02799745
A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance
Phase 2
Completed
227 enrolled
Astellas Pharma Global Development, Inc.
Medivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this study was to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.
Timeline
- Start
- 2016-06-09
- Primary completion
- 2020-08-28
- Completion
- 2020-08-28
Publications
- Handa N, Shore ND, Cooperberg MR, Davicioni E, Zhao X, Elsouda D, Liu Y, Proudfoot JA, Kuperman G, Russell D, Iwata KK, Schaeffer EM, Ross A. Transcriptome profiling of prostatic tumours from ENACT trial patients with or without enzalutamide. BJU Int. 2025 Nov;136(5):920-929. doi: 10.1111/bju.16861. Epub 2025 Jul 31.
- Ross AE, Iwata KK, Elsouda D, Hairston J, Russell D, Davicioni E, Proudfoot JA, Shore ND, Schaeffer EM. Transcriptome-Based Prognostic and Predictive Biomarker Analysis of ENACT: A Randomized Controlled Trial of Enzalutamide in Men Undergoing Active Surveillance. JCO Precis Oncol. 2024 Apr;8:e2300603. doi: 10.1200/PO.23.00603.
- Shore ND, Renzulli J, Fleshner NE, Hollowell CMP, Vourganti S, Silberstein J, Siddiqui R, Hairston J, Elsouda D, Russell D, Cooperberg MR, Tomlins SA. Enzalutamide Monotherapy vs Active Surveillance in Patients With Low-risk or Intermediate-risk Localized Prostate Cancer: The ENACT Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1128-1136. doi: 10.1001/jamaoncol.2022.1641.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Enzalutamide | Other / unclassified | 160 mg | Oral |