ERLEADA plus ADT cuts recurrence or death risk by 62% in high-risk prostate cancer substudy

Posted on October 26, 2026

Johnson & Johnson has reported new Phase III data showing that ERLEADA, also known as apalutamide, combined with androgen deprivation therapy before and after surgery significantly reduced the risk of disease recurrence or death in patients with high-risk localised or locally advanced prostate cancer.

The findings come from a substudy of the PROTEUS trial and were presented as a late-breaking abstract at the 2026 European Society for Medical Oncology Congress.

The substudy directly compared six months of apalutamide plus androgen deprivation therapy before and after radical prostatectomy with surgery alone.

A total of 408 patients with newly diagnosed, non-metastatic, high-risk localised or locally advanced prostate cancer were included.

At a median follow-up of 37.8 months, perioperative apalutamide plus androgen deprivation therapy reduced the risk of disease recurrence or death by 62% compared with radical prostatectomy alone.

The hazard ratio for event-free survival was 0.38, with a 95% confidence interval of 0.26 to 0.55 and a p value below 0.0001.

Median event-free survival had not been reached in the apalutamide group, compared with 19.1 months among patients undergoing surgery alone.

At three years, 63% of patients receiving apalutamide plus androgen deprivation therapy remained event-free compared with 41.4% of patients treated with surgery alone.

The study defined event-free survival as the time until biochemical failure, local or regional recurrence, distant metastasis or death.

The combination also produced a numerical improvement in metastasis-free survival.

Patients receiving apalutamide plus androgen deprivation therapy had a 51% lower estimated risk of distant metastasis or death compared with surgery alone, with a hazard ratio of 0.49.

Treatment also delayed the need for further cancer therapy.

The risk of requiring subsequent treatment was 71% lower with the perioperative regimen, producing a hazard ratio of 0.29.

At three years, 64.6% of patients receiving apalutamide plus androgen deprivation therapy had not required another treatment compared with 32% of patients receiving surgery alone.

Alberto Briganti, MD, Professor of Urology and Urologic Surgeon at IRCCS San Raffaele Hospital in Milan, said recurrence remains an important concern for patients undergoing curative-intent surgery for aggressive prostate cancer.

He said the reduction in recurrence and metastasis observed with perioperative apalutamide suggests systemic treatment could improve longer-term disease control when added to surgery.

The findings build on the primary PROTEUS results presented at the 2026 American Society of Clinical Oncology Annual Meeting.

Yusri Elsayed, MD, MHSc, PhD, Global Therapeutic Area Head of Oncology at Johnson & Johnson, said the substudy was designed to directly evaluate the treatment strategy against surgery alone, which has long been a standard approach for high-risk localised prostate cancer.

The safety profile was consistent with findings from the main PROTEUS study.

Grade 3 or 4 treatment-emergent adverse events occurred in 31% of patients receiving apalutamide plus androgen deprivation therapy compared with 22% of those receiving surgery alone.

No treatment-emergent adverse events resulting in death were reported in either group.

The most frequently reported adverse events with apalutamide included hot flushes, occurring in 64% of patients, and urinary incontinence, reported in 63%.

Additional follow-up is underway to evaluate overall survival.

Apalutamide plus androgen deprivation therapy has not been approved by regulatory authorities for high-risk localised or locally advanced prostate cancer.

ERLEADA plus ADT cuts recurrence or death risk by 62% in high-risk prostate cancer substudy

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