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An international phase 3 clinical trial that treated patients with high-risk localized and locally advanced prostate cancer with apalutamide—a next-generation neoadjuvant androgen-receptor pathway inhibitor (ARPI)—plus hormone therapy before and after prostate cancer surgery was further validated by a substudy demonstrating a reduced risk of metastasis or death compared with standard of care.

The substudy, co-led by principal investigator Mary-Ellen Taplin, M.D., a medical oncologist at Dana-Farber Cancer Institute, was presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain, and published today in European Urology. Alberto Briganti, M.D., Ph.D., professor of urology at Vita-Salute San Raffaele University in Milan, Italy, presented the data at ESMO.

Previous Dana-Farber research led by Taplin, presented earlier this year at the American Society for Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, found that apalutamide plus androgen-deprivation hormone therapy (ADT) prior to and after surgery showed significant promise for patients with high-risk localized prostate cancer.

Patients treated with the apalutamide plus hormone therapy regimen were nine times more likely to have little to no cancer present at surgery. The regimen reduced the risk of metastases or death by 20% and delayed subsequent therapy by 33 months compared with ADT alone.

The substudy compared the novel perioperative approach to standard of care, radical prostatectomy alone.

"Following the presentation of the PROTEUS results at ASCO, an important question remained: how does this regimen compare with standard-of-care prostatectomy?

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