Study of [177Lu]Lu-PSMA-137 In Metastatic Castrate Resistant Prostate Cancer（mCRPC）

Summary

This study is a prospective, single-center, single-arm clinical trial consisting of two parts. In Part A, 3 participants were enrolled to receive sequential administrations of low doses of \[177Lu\]Lu-PSMA-137 and \[177Lu\]Lu-PSMA-617. Pharmacokinetics（PK） sampling and single-photon emission computed tomography/computed tomography (SPECT/CT) scans were performed at scheduled time according to the protocol. Based on quantitative pharmacological results, the optimal dosing regimen for \[177Lu\]Lu-PSMA-137 was derived. In Part B, 3 participants were enrolled to receive treatments with 50% and 100% of the optimal dose of \[177Lu\]Lu-PSMA-137, to preliminarily evaluate the safety, tolerability, radiation dosimetry, and efficacy of \[177Lu\]Lu-PSMA-137 in participants with metastatic castration resistant prostate cancer (mCRPC).

Timeline

Start

2024-08-01

Primary completion

2025-03-01

Completion

2026-12-01

Drugs

Indications