Enzalutamide in Metastatic Prostate Cancer before Chemotherapy
Open accessAbstract
BACKGROUND: Enzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy. New treatment options are needed for patients with metastatic prostate cancer who have not received chemotherapy, in whom the disease has progressed despite androgen-deprivation therapy. METHODS: In this double-blind, phase 3 study, we randomly assigned 1717 patients to receive either enzalutamide (at a dose of 160 mg) or placebo once daily. The coprimary end points were radiographic progression-free survival and overall survival. RESULTS: The study was stopped after a planned interim analysis, conducted when 540 deaths had been reported, showed a benefit of the active treatment. The rate of radiographic progression-free survival at 12 months was 65% among patients treated with enzalutamide, as compared with 14% among patients receiving placebo (81% risk reduction; hazard ratio in the enzalutamide group, 0.19; 95% confidence interval [CI], 0.15 to 0.23; P<0.001). A total of 626 patients (72%) in the enzalutamide group, as compared with 532 patients (63%) in the placebo group, were alive at the data-cutoff date (29% reduction in the risk of death; hazard ratio, 0.71; 95% CI, 0.60 to 0.84; P<0.001). The benefit of enzalutamide was shown with respect to all secondary end points, including the time until the initiation of cytotoxic chemotherapy (hazard ratio, 0.35), the time until the first skeletal-related event (hazard ratio, 0.72), a complete or partial soft-tissue response (59% vs. 5%), the time until prostate-specific antigen (PSA) progression (hazard ratio, 0.17), and a rate of decline of at least 50% in PSA (78% vs. 3%) (P<0.001 for all comparisons). Fatigue and hypertension were the most common clinically relevant adverse events associated with enzalutamide treatment. CONCLUSIONS: Enzalutamide significantly decreased the risk of radiographic progression and death and delayed the initiation of chemotherapy in men with metastatic prostate cancer. (Funded by Medivation and Astellas Pharma; PREVAIL ClinicalTrials.gov number, NCT01212991.).
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Multiple phase 3 clinical trials have demonstrated the benefit of AR-targeted therapies on patient survival.
“Multiple phase 3 clinical trials have demonstrated the benefit of AR-targeted therapies on patient survival9–18.”
From Genome-scale CRISPR screens identify PTGES3 as a direct modulator of androgen receptor function in advanced prostate cancer (2025) · cites this paper as [10]
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- Authors
- Beer, T. M., Armstrong, A. J., Rathkopf, D. E., Loriot, Y., Sternberg, C. N., Higano, C. S., Iversen, P., Bhattacharya, S., Carles, J., Chowdhury, S., Davis, I. D., de Bono, J. S., Evans, C. P., Fizazi, K., Joshua, A. M., Kim, C.-S., Kimura, G., Mainwaring, P., Mansbach, H., Miller, K., Noonberg, S. B., Perabo, F., Phung, D., Saad, F., Scher, H. I., Taplin, M.-E., Venner, P. M., & Tombal, B.
- Affiliations
- Oregon Health & Science University (US)
- Duke University (US)
- Memorial Sloan Kettering Cancer Center (US)
- Université Paris-Sud (FR)
- Azienda Ospedaliera San Camillo-Forlanini (IT)
- Seattle Cancer Care Alliance (US)
- University of Copenhagen (DK)
- Medivation, Inc. (United States) (US)
- Vall d'Hebron Hospital Universitari (ES)
- Guy's Hospital (GB)
- Eastern Health (AU)
- UC Davis Comprehensive Cancer Center (US)
- Princess Margaret Cancer Centre (CA)
- Asan Medical Center (KR)
- Nippon Medical School (JP)
- Icon (Australia) (AU)
- Charité – Universitätsmedizin Berlin (DE)
- Astellas Pharma (United States) (US)
- Dana-Farber Cancer Institute (US)
- University of Alberta (CA)
- Cliniques Universitaires Saint-Luc (BE)
- ORCID
- Beer, Tomasz M.
- Armstrong, Andrew J.
- Rathkopf, Dana E.
- Loriot, Yohann
- Sternberg, Cora N.
- Higano, Celestia S.
- Iversen, Peter
- Carles, Joan
- Davis, Ian D.
- Evans, Christopher P.
- Fizazi, Karim
- Joshua, Anthony M.
- Kim, Choung-Soo
- Kimura, Go
- Mainwaring, Paul
- Miller, Kurt
- Noonberg, Sarah B.
- Scher, Howard I.
- Taplin, Mary-Ellen
- Tombal, Bertrand
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-07-31
- Volume
- 371
- Issue
- 5
- Pages
- 424-433
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4418931
- OpenAlex
- W2166918329
- Cited by
- 3,028
- References
- 27
- Citations by year
- 2026: 112 · 2025: 159 · 2024: 216 · 2023: 214 · 2022: 255 · 2021: 292 · 2020: 314 · 2019: 287 · 2018: 272 · 2017: 285 · 2016: 295 · 2015: 244 · 2014: 71 · 2013: 3
- FWCI
- 239.40
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- Tampere University Institutional Repository (Tampere University) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
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- HAL (submittedVersion)
- Digital Access to Libraries (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Tampere University Institutional Repository (Tampere University) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion, other-oa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Funders
- Oregon Health and Science University
- Memorial Sloan-Kettering Cancer Center
- University of Washington
- University of Alberta
- Monash University
- Astellas Pharma
- Rigshospitalet
- Université de Montréal
- Institut Gustave-Roussy
- Fundació Institut de Recerca Hospital Universitari Vall d’Hebron
- Weill Cornell Medical College
- Astellas Pharma Global Development
- University of California, Davis
- Knight Cancer Institute, Oregon Health and Science University
- National Cancer Institute (P30CA008748, P30CA014236, P30CA069533)
- Duke Cancer Institute
- Cliniques Universitaires Saint-Luc
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- enzalutamide, metastatic castration-resistant prostate cancer, androgen receptor antagonists, progression-free survival, overall survival, skeletal-related events, PSA response, androgen deprivation therapy, fatigue, hypertension, adverse events, soft tissue response
- MeSH terms
- Adenocarcinoma, Administration, Oral, Benzamides, Double-Blind Method, Humans, Male, Neoplasm Metastasis, Nitriles, Phenylthiohydantoin, Prostatic Neoplasms, Radiography, Receptors, Androgen, Survival Analysis, Disease Progression, Antineoplastic Agents, Hormonal, Androgen Receptor Antagonists
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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