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Predictive value of early PSMA upregulation for the response to enzalutamide ± 177Lu-PSMA-617 in poor-risk, metastatic, castration-resistant prostate cancer: substudy of the randomized, phase 2 ENZA-p trial

Nature Cancer (2026)Cite this article

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Abstract

Prostate-specific membrane antigen (PSMA) receptor expression alters with androgen blockade in metastatic castrate-resistant prostate cancer (mCRPC). We evaluated the frequency and significance of early PSMA-positron emission tomography (PET) standardized uptake value (SUV) mean change with enzalutamide ± 177Lu-PSMA-617. ENZA-p is a randomized trial. Participants had mCRPC and 68Ga-PSMA positive disease. Participants were randomized (1:1) to enzalutamide or enzalutamide + 177Lu-PSMA-617, undergoing 68Ga-PSMA-PET–computed tomography (CT) at baseline and day 15 of enzalutamide treatment. 68Ga-PSMA-PET–CT were quantified for SUV mean. The study evaluated early SUV mean change, and prostate-specific-antigen (PSA) progression-free survival (PSA-PFS), 50% PSA-decline and overall survival. We randomized 162 participants, of whom 154 of 160 (96%) treated participants had PSMA-PET at day 15. SUV mean increased in 105 of 154 (68%) participants. Median PSA-PFS with increasing SUV mean was 5.8 (95% confidence interval (CI) 4.0–8.7) versus 13.1 (95%CI 10.5–17.0) months for enzalutamide versus enzalutamide + 177Lu-PSMA-617 (hazard ratio (HR) 0.38, 95%CI 0.25–0.58; log-rank P < 0.001). With decreasing SUV mean, median PSA-PFS was 12.5 (95%CI 3.2–23.6) versus 13.3 (95%CI 9.6–22.2) months for enzalutamide versus enzalutamide + 177Lu-PSMA-617 (HR 0.80, 95%CI 0.42–1.53; log-rank P = 0.5). The interaction between SUV mean increase or decrease and treatment arm for PSA-PFS was P = 0.055. Early PSMA-SUV mean increase is frequent, predicting shorter PSA-PFS with first-line enzalutamide in mCRPC. The addition of 177Lu-PSMA-617 to enzalutamide mitigated the short PSA-PFS in those with early PSMA SUV mean increase. ClinicalTrials.gov registration: NCT04419402.

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Fig. 1: Total body quantitation on PSMA-PET undertaken at baseline and day 15 after commencing enzalutamide.
Fig. 2: Change in SUV mean.
Fig. 3: Impact of change in SUV mean on PSA-PFS.
Fig. 4: Impact of treatment arm and change in SUV mean on best PSA response.
Fig. 5: Impact of change in SUV mean and treatment arm on overall survival.

Data availability

The data that support the findings of this study are available from the corresponding author upon request. Requests for specific analyses or data will be considered by the ENZA-p trial executive committee. Proposals should be directed to the corresponding author; to gain access, data requestors will need to sign a data access agreement. Source data are provided with this paper.

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Acknowledgements

ENZA-p is an investigator-initiated trial led by the ANZUP Cancer Trials Group in partnership with the Prostate Cancer Research Alliance, a joint initiative between the Australian Federal Government and the Movember Foundation. ENZA-p is a collaboration between ANZUP, the NHMRC Clinical Trials Centre at the University of Sydney and the Australasian Radiopharmaceutical Trials Network with support from AdAcAp (a Novartis company), St Vincent’s Clinic Foundation, GenesisCare and Roy Morgan Research. Astellas provided drug support for the trial. ANZUP receives infrastructure funding from Cancer Australia. This substudy was funded through a prostate cancer foundation challenge award. We acknowledge and thank the 162 participants for their participation in the ENZA-p study; and the principal investigators, co-investigators and study coordinators at the 15 centers across Australia for their dedication and enthusiasm.

Author information

Author notes

  1. These authors contributed equally: Martin R. Stockler, Ian D. Davis.

  2. A full list of members and their affiliations appears in the Supplementary Information.

Authors and Affiliations

  1. Department of Theranostics and Nuclear Medicine, St Vincent’s Hospital, Sydney, New South Wales, Australia

    Louise Emmett, Mina Swiha, Andrew Nguyen, Sarennya Pathmanandavel & Narjess Ayati

  2. St Vincent’s Clinical School, University of New South Wales, Sydney, New South Wales, Australia

    Louise Emmett, Megan Crumbaker, Anthony M. Joshua & Narjess Ayati

  3. Garvan Institute of Medical Research, Sydney, New South Wales, Australia

    Louise Emmett, Nathan Papa, Megan Crumbaker, Anthony M. Joshua & Narjess Ayati

  4. Molecular Imaging and Theranostics Division, Department of Medical Imaging, University of Western Ontario, London, Ontario, Canada

    Mina Swiha

  5. NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia

    Shalini Subramaniam, Claire Niu, Andrew J. Martin, Hayley Thomas & Martin R. Stockler

  6. Department of Medical Oncology, Bankstown-Lidcombe Hospital, Sydney, New South Wales, Australia

    Shalini Subramaniam

  7. Department of Medical Oncology, Kinghorn Cancer Centre, St Vincent’s Hospital, Sydney, New South Wales, Australia

    Megan Crumbaker & Anthony M. Joshua

  8. Olivia Newton-John Cancer and Wellness Centre, Austin Health, Melbourne, Victoria, Australia

    Andrew Weickhardt

  9. School of Cancer Medicine, La Trobe University, Melbourne, Victoria, Australia

    Andrew Weickhardt

  10. Olivia Newton-John Cancer Research Institute, Melbourne, Victoria, Australia

    Andrew Weickhardt

  11. Department of Molecular Imaging and Therapy, Austin Health, Melbourne, Victoria, Australia

    Sze-Ting Lee

  12. Department of Oncology, Sir Charles Gairdner Hospital and University of Western Australia, Perth, Western Australia, Australia

    Siobhan Ng

  13. Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia

    Roslyn J. Francis

  14. Medical School, University of Western Australia, Perth, Western Australia, Australia

    Roslyn J. Francis

  15. Royal Brisbane & Women’s Hospital, Herston, Queensland, Australia

    Roslyn J. Francis, Jeffrey C. Goh & David A. Pattison

  16. School of Medicine, University of Queensland, Brisbane, Queensland, Australia

    Jeffrey C. Goh & David A. Pattison

  17. Department of Nuclear Medicine & Specialised PET Services, Royal Brisbane and Women’s Hospital, Herston, Brisbane, Queensland, Australia

    David A. Pattison

  18. Department of Nuclear medicine, St George Hospital Sydney, Sydney, New South Wales, Australia

    Sarennya Pathmanandavel

  19. Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA

    Thomas Hope

  20. Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

    Michael S. Hofman

  21. Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia

    Shahneen Sandhu

  22. University of Sydney, Sydney, New South Wales, Australia

    Martin R. Stockler

  23. Monash University Eastern Health Clinical School, Melbourne, Victoria, Australia

    Ian D. Davis

  24. Eastern Health, Melbourne, Victoria, Australia

    Ian D. Davis

  25. Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, New South Wales, Australia

    Ian D. Davis

Authors
  1. Louise Emmett
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  2. Mina Swiha
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  7. Andrew Nguyen
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  8. Andrew Weickhardt
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  9. Sze-Ting Lee
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  10. Siobhan Ng
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  11. Roslyn J. Francis
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  12. Jeffrey C. Goh
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  14. Sarennya Pathmanandavel
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  15. Thomas Hope
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  16. Narjess Ayati
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  17. Michael S. Hofman
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  18. Shahneen Sandhu
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  23. Ian D. Davis
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Consortia

on behalf of the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group

  • Louise Emmett
  • , Shalini Subramaniam
  • , Megan Crumbaker
  • , Anthony M. Joshua
  • , Andrew Nguyen
  • , Andrew Weickhardt
  • , Sze-Ting Lee
  • , Siobhan Ng
  • , Roslyn J. Francis
  • , Jeffrey C. Goh
  • , David A. Pattison
  • , Sarennya Pathmanandavel
  • , Narjess Ayati
  • , Michael S. Hofman
  • , Shahneen Sandhu
  • , Claire Niu
  • , Andrew J. Martin
  • , Hayley Thomas
  • , Martin R. Stockler
  •  & Ian D. Davis

Contributions

L.E., N.P., M.C., A.J.M., N.A., M.R.S., S. Sandhu, M.S.H., I.D.D. were members of the research group who developed the prespecified ENZA-p translational analysis plan and PCF challenge award, also contributing to conceptualization and writing the first version of the protocol. L.E., S. Subramaniam, M.C., A.M.J., A.N., A.W., S.-T.L., T.H., C.N.,. S.N., R.J.F., S. Sandhu, M.S.H., J.C.G. D.P., M.R.S. and I.D.D. accrued patients and collected data. L.E., A.N., M.S. and S.P. performed imaging quantitative analysis. N.P., L.E. and H.T. led the statistical analysis and verified underlying data. S. Subramaniam reviewed data on adverse events, response and progression-free survival. L.E., N.P., I.D.D., M.R.S., A.J.M., H.T. and S. Subramaniam have accessed and verified the data. L.E. was the co-ordinating principal investigator and wrote the first draft of the manuscript. All authors contributed to the writing and approval of the manuscript. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Corresponding author

Correspondence to Louise Emmett.

Ethics declarations

Competing interests

L.E. reports research grant support (to their institution) from Novartis and Clarity Pharma; consulting fees for lectures or advisory boards from Astellas, Advancell, Janssen, AstraZeneca, Clarity, Novartis, Advancell and Telix in the past 5 years; and philanthropic grant support from the Prostate Cancer Foundation, St Vincent’s Clinic Research Foundation and Curran Foundation. S. Sandhu, reports grants from Novartis/AAA, AstraZeneca, Merck Sharp & Dohme, Genentech, Pfizer, Amgen and Senhwa to their institution; and personal fees from AstraZeneca, Merck Sharp & Dohme, Bristol Myers Squibb and AstraZeneca to their institution, outside the submitted work. M.S.H. reports grants and receipt of equipment, materials, drugs, medical writing, gifts or other services from the Prostate Cancer Foundation, National Health and Medical Research Council (NHRMC), Movember, US Department of Defense, Medical Research Future Fund, Bayer, Peter MacCallum Foundation, Isotopia and the Australian Nuclear Science and Technology Organisation; consulting fees from Merck Sharp & Dohme and Novartis; honoraria from Janssen, Novartis, AstraZeneca and Astellas; support for meetings from Merck Sharp & Dohme, Novartis, Janssen, AstraZeneca and Astellas; leadership or fiduciary role in other board from Australian Friends of Sheba; and other financial or non-financial interests from Peter MacCallum Cancer Centre and the University of Melbourne. D.P. reports personal fees from Ipsen and Eisai, all outside the submitted work. R.J.F. reports institution funding and consulting fees from AIQ Solutions, outside the submitted work; and committee involvement in the Australasian Radiopharmaceutical Trials Network (unpaid). M.R.S. reports grants to his institution from the Australian NHMRC, Cancer Australia, Astellas, Amgen, AstraZeneca, Bayer, Bionomics, Bristol Myers Squibb, Celgene, Medivation, Merck Sharp & Dohme, Pfizer, Roche, Sanofi and Tilray, all outside the submitted work. I.D.D. reports grants from the NHMRC, during the conduct of the study; and institutional payments to support prostate cancer trials from Pfizer, ANZUP Cancer Trials Group, Bayer, Astellas, Janssen, Movember Foundation and Merck Sharp & Dohme, outside the submitted work. I.D.D. is unremunerated Chair of the ANZUP Cancer Trials Group and is supported in part by an Australian NHMRC Investigator Grant (grant number 2016274). A.M.J. reports consulting or advisory roles (to their institution) from Janssen Oncology, Pfizer and Astellas Pharma; and research funding (to their institution) from Bristol Myers Squibb, Janssen Oncology, Merck Sharp & Dohme, Mayne Pharma, Roche/Genentech, Bayer, Lilly, Pfizer and AstraZeneca. A.W. declares consulting fees from MSD, Eisai, Bristol Myers Squibb and Astellas; honoraria from Eisai and MSD; and participation on an advisory board from Loxo-Lilly, MSD and Astellas. D.P. declares support for travel from Astellas and participation on an advisory board from Astellas. The other authors declare no competing interests.

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Extended data

Extended Data Fig. 1 Reproducibility of SUV mean.

Bland Altman Plot for Reproducibility of Whole Body SUVmean.

Source data

Extended Data Fig. 2 PSMA SUV mean change extent and impact on PSA-PFS and OS.

Impact of Extent of PSMA SUVmean change by Day 15 on likelihood of additional benefit with the Addition of 177LuPSMA-617 to enzalutamide for PSA-PFS and OS.

Supplementary information

Source data

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Emmett, L., Swiha, M., Papa, N. et al. Predictive value of early PSMA upregulation for the response to enzalutamide ± 177Lu-PSMA-617 in poor-risk, metastatic, castration-resistant prostate cancer: substudy of the randomized, phase 2 ENZA-p trial. Nat Cancer (2026). https://doi.org/10.1038/s43018-026-01140-3

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