Mihir Shah, MD, on emerging neoadjuvant strategies in localized prostate cancer

In a recent interview with Urology Times®, Mihir S. Shah, MD, outlined emerging research around treatment intensification prior to radical prostatectomy in patients with unfavorable intermediate- or high-risk localized prostate cancer.¹ Shah specifically pointed to ongoing trials looking at antigen receptor signaling inhibitors in combination with androgen deprivation therapy (ADT) as well as ongoing work exploring immunotherapy and radioligand therapy.

Shah is a urologic oncologist and clinical assistant professor at Thomas Jefferson University in Philadelphia, Pennsylvania.

Shah first highlighted the phase 3 PROTEUS trial (NCT03767244), which is evaluating the combination of apalutamide (Erleada) plus ADT vs placebo plus ADT prior to radical prostatectomy in patients with localized high-risk or locally advanced prostate cancer.²

The dual primary end points for the study are pathologic complete response rate and metastasis-free survival. Primary completion for the PROTEUS trial is expected in February 2026.

Shah also mentioned a phase 1 trial (NCT06613100) of xaluritamig (AMG 509), a STEAP1-targeted T-cell engager for localized prostate cancer. The study is specifically assessing the safety and efficacy of xaluritamig administered in the neoadjuvant setting. Primary completion is anticipated in September 2026.³

REFERENCES

1. Kerkvliet CJP, Leong JY, Thompson RAM, et al. Treatment intensification prior to radical prostatectomy for clinically localized prostate cancer. Cancers (Basel). 2025;17(13):2258. doi:10.3390/cancers17132258

2. A study of apalutamide in participants with high-risk, localized or locally advanced prostate cancer who are candidates for radical prostatectomy (PROTEUS). ClinicalTrials.gov. Last updated September 12, 2025. Accessed September 26, 2025. https://clinicaltrials.gov/study/NCT03767244

3. Evaluation of neoadjuvant xaluritamig in localized prostate cancer. ClinicalTrials.gov. Last updated July 29, 2025. Accessed September 26, 2025. https://clinicaltrials.gov/study/NCT06613100