ENZARAD (ANZUP 1303): Phase 3 Trial of Enzalutamide With Androgen Deprivation Therapy and Radiation Therapy in High-Risk Localized or Locally Advanced Prostate Cancer

Background The effects of adding enzalutamide to androgen deprivation therapy (ADT) and radiotherapy for high-risk localized or locally advanced prostate cancer were unknown. Methods Open-label, phase 3 trial of definitive prostate radiotherapy with 24 months of ADT and 1:1 randomization to either enzalutamide (160mg daily for 24 months) or an older nonsteroidal antiandrogen (NSAA) for 6 months. The primary endpoint was metastasis-free survival on conventional imaging (MFS-CI) with computerized tomography and/or 99m Tc-bone scintigraphy. Radiation to pelvic lymph nodes was required for cN1 disease but optional for cN0. Results 802 participants were randomized. After a median follow-up of 92 months, 207 MFS-CI events were reported (98 enzalutamide, 109 NSAA) with 8-year MFS-CI rates 74% vs 72%, hazard ratio [HR] 0.88, 95% confidence interval [CI], 0.67 to 1.15; P =0.34). Prespecified subgroup analyses noted enzalutamide was associated with a possible MFS-CI benefit in the subgroup undergoing planned pelvic nodal radiotherapy, N=324 (HR 0.47, 95% CI: 0.29 to 0.76 P adjusted =0.004). Grade 3-5 adverse events were reported in 185 participants in each arm. Conclusions The use of enzalutamide rather than NSAA in addition to radiotherapy and ADT for 2 years showed no significant MFS-CI or OS improvement at 8 years.

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Publication Details

Journal
Journal of Clinical Oncology
Published
2026-10-24
DOI
https://doi.org/10.1200/jco-26-01794
Primary Topic
Prostate Cancer Diagnosis and Treatment
Type
article
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article

ENZARAD (ANZUP 1303): Phase 3 Trial of Enzalutamide With Androgen Deprivation Therapy and Radiation Therapy in High-Risk Localized or Locally Advanced Prostate Cancer

Leanna Cheung, Annette Haworth, Christopher J. Sweeney, Sonia Yip et al.
Journal of Clinical Oncology
Prostate Cancer Diagnosis and Treatment
article

ENZARAD (ANZUP 1303): Phase 3 Trial of Enzalutamide With Androgen Deprivation Therapy and Radiation Therapy in High-Risk Localized or Locally Advanced Prostate Cancer

Leanna Cheung, Annette Haworth, Christopher J. Sweeney, Sonia Yip, Ray McDermott, Carys W. Thomas, Paul Linh Nguyen, Paul J Kelly, Tee Sin Lim, Andrew James Martin, Blossom Mak, Simon Peter Gampenrieder, Simon R. Hughes, David I. Pryor, Martin R. Stockler, Ian D. Davis, Hayley Thomas, Alina Mihai, Phuong Nguyen Tran, Stephen A. Mangar, Scott Williams, Nitya Patanjali, Sandra Lee, Chakiath C. Jose, Alison Zhang, Anna Walsh, Jarad Martin, Annabelle Goodwin
article en

Abstract

Background The effects of adding enzalutamide to androgen deprivation therapy (ADT) and radiotherapy for high-risk localized or locally advanced prostate cancer were unknown. Methods Open-label, phase 3 trial of definitive prostate radiotherapy with 24 months of ADT and 1:1 randomization to either enzalutamide (160mg daily for 24 months) or an older nonsteroidal antiandrogen (NSAA) for 6 months. The primary endpoint was metastasis-free survival on conventional imaging (MFS-CI) with computerized tomography and/or 99m Tc-bone scintigraphy. Radiation to pelvic lymph nodes was required for cN1 disease but optional for cN0. Results 802 participants were randomized. After a median follow-up of 92 months, 207 MFS-CI events were reported (98 enzalutamide, 109 NSAA) with 8-year MFS-CI rates 74% vs 72%, hazard ratio [HR] 0.88, 95% confidence interval [CI], 0.67 to 1.15; P =0.34). Prespecified subgroup analyses noted enzalutamide was associated with a possible MFS-CI benefit in the subgroup undergoing planned pelvic nodal radiotherapy, N=324 (HR 0.47, 95% CI: 0.29 to 0.76 P adjusted =0.004). Grade 3-5 adverse events were reported in 185 participants in each arm. Conclusions The use of enzalutamide rather than NSAA in addition to radiotherapy and ADT for 2 years showed no significant MFS-CI or OS improvement at 8 years.

Journal of Clinical Oncology
University College Dublin (IE), The University of Sydney (AU), Harvard University (US), The University of Queensland (AU), Guy's and St Thomas' NHS Foundation Trust (GB), Concord Repatriation General Hospital (AU), Peter MacCallum Cancer Centre (AU), Fiona Stanley Hospital (AU), Auckland City Hospital (NZ), Princess Alexandra Hospital (AU), Beaumont Hospital (IE), Charing Cross Hospital (GB), Cork University Hospital (IE), The University of Arizona Global Campus (US), UNSW Sydney (AU), Chris O’Brien Lifehouse (AU), Eastern Health (AU), Cancer Trials Ireland (IE), Dana-Farber Cancer Institute (US), Kent and Canterbury Hospital (GB), Trans Tasman Radiation Oncology Group (AU), Centre for Cancer Biology (AU), Salzburger Landeskliniken (AT), Calvary Mater Newcastle Hospital (AU), Australian and New Zealand Urogenital and Prostate Cancer Trials Group (AU), GenesisCare (AU), University College London (GB), Monash University (AU)
Openalex Percentile: Top 12%
Prostate Cancer Diagnosis and Treatment
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