A Phase 2, Open-Label, Randomized Controlled Trial Evaluating Safety and Efficacy of Dose-Intensified Versus Standard Dosing Regimens of [ 177 Lu]Lu-PSMA-597 in mCRPC (OPTIMAL-PSMA).
J Nucl MedOct 1, 2026 (epub)
Sobia Khan, Nathan Papa, Takanori Hioki et al.
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In 30 seconds
The OPTIMAL-PSMA study is a Phase 2, open-label, randomized controlled trial evaluating the safety and efficacy of a dose-intensified regimen of [177Lu]Lu-PSMA-597 versus standard dosing in 120 patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint is a 90% or greater decline in prostate-specific antigen (PSA) levels, with the trial aiming to improve treatment outcomes for this patient population.
Key findings
- The primary endpoint is a 90% or greater decline in PSA levels.
- Participants will be randomized 2:1 to receive either dose-intensified or standard dosing.
- Safety assessments will occur three times weekly throughout the trial.
- Key secondary endpoints include overall survival and radiographic progression-free survival.
Why it matters
This study addresses a critical need for improved treatment strategies in mCRPC, potentially leading to enhanced patient outcomes through optimized dosing regimens of PSMA-targeted therapies.