Clinical Trial Protocol for LPS-Boost: Intensified [ 177 Lu]Lu-PSMA-617 Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with Low PSMA-Expressing Disease.
J Nucl MedOct 1, 2026 (epub)
Amir Iravani, Roman Gulati, Robert Miyaoka et al.
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In 30 seconds
This multicenter, open-label phase 2 trial investigates an intensified treatment schedule of [177Lu]Lu-PSMA-617 for 45 patients with metastatic castration-resistant prostate cancer (mCRPC) and low PSMA expression. The study aims to improve prostate-specific antigen (PSA) progression-free survival in this subgroup, which typically shows poorer outcomes with standard treatment. The primary endpoint is PSA progression-free survival.
Key findings
- Participants will receive up to 6 cycles of [177Lu]Lu-PSMA-617 at an intensified cadence.
- The primary endpoint is PSA progression-free survival, with safety as a key secondary endpoint.
- A continuous safety monitoring rule allows early termination for significant adverse hematologic events.
Why it matters
This trial addresses the challenge of variable response rates in mCRPC patients with low PSMA expression, potentially leading to improved treatment strategies and outcomes for this difficult-to-treat population.