A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC

Summary

The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of \[177Lu\]Lu-PSMA-617 when administered in addition to Best Supportive/Best Standard of Care (BSC/BSoC) in Chinese participants with progressive PSMA-positive mCRPC who received at least 1 novel androgen receptor pathway inhibitor (ARPI) and were previously treated with 1 to 2 taxane regimens. Furthermore, the safety, PK, and dosimetry of \[68Ga\]Ga-PSMA-11 were assessed. Data from this study will be used to bridge global pivotal phase III study (VISION, AAA617A12301) and to support China registration of \[177Lu\]Lu-PSMA-617 as a novel anticancer modality, namely radioligand therapy, in mCRPC.

Timeline

Start

2023-05-16

Primary completion

2024-05-17

Completion

2026-04-22

Publications

• Shi H, Guo J, Fan W, Li Y, Huang R, Dong Q, Yang Z, Yang Y, Wang X, Gu D, Huo L, Ji Z, Wang F, Xu D, Jiang Z, Li H, Li J, Li R, Qi L, Wang J, Ye D. A phase II study evaluating pharmacokinetics and dosimetry of 177Lu-PSMA-617 radioligand therapy in Chinese participants with progressive metastatic castration-resistant prostate cancer. EJNMMI Res. 2026 Mar 1;16(1):55. doi: 10.1186/s13550-026-01401-3.

Drugs

Indications