DOI: 10.1200/jco-26-01794 ISSN: 0732-183X

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

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