Pharmacokinetics and dosimetry of [¹⁷⁷Lu]Lu-PSMA-617 and [⁶⁸Ga]Ga-PSMA-11 in Japanese patients with PSMA-positive mCRPC.

ABSTRACT:

Objective

This prospective, open-label, single-arm, phase 2 study evaluated the efficacy, safety, pharmacokinetics (PK) and dosimetry of [¹⁷⁷Lu]Lu-PSMA-617 in Japanese patients with progressive PSMA+ mCRPC.

Methods

This is a PK/dosimetry analysis of [⁶⁸Ga]Ga-PSMA-11 and [¹⁷⁷Lu]Lu-PSMA-617 in patients from Parts 1, 2, and 3 of the 4-part study. Blood and urine samples, serial PET/CT, planar, and SPECT/CT scans were collected post-administration of [⁶⁸Ga]Ga-PSMA-11 (111-259 MBq) at screening and [¹⁷⁷Lu]Lu-PSMA-617 (7.4 GBq ± 10%) during cycle 1. External radiation exposure in medical personnel and family members was measured once in each cycle from cycle 1 to 6, excluding the cycle where dosimetry was performed.

Results

SUBMITTER: Takano S 

PROVIDER: S-EPMC12559119 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature