PRINCE (PSMA-lutetium Radionuclide Therapy and ImmuNotherapy in Prostate CancEr)

Summary

This investigator driven study will examine the safety, tolerability and efficacy of the combination of 177Lutetium-PSMA (177Lu-PSMA) and pembrolizumab in patients with metastatic Castration Resistant Prostate Cancer (mCRPC). 177Lu-PSMA is a compound that binds to the extra-cellular domain of the prostate-specific membrane antigen. Pembrolizumab is an antibody targeted against anti-programmed cell death 1 (PD-1).This is a single arm study where all patients will be treated with 177Lu-PSMA for upto 6 doses and pembrolizumab for upto 35 cycles.

Timeline

Start

2019-07-12

Primary completion

2022-12-22

Completion

2022-12-22

Publications

• Sandhu S, Joshua AM, Emmett L, Bressel M, Anton A, Spain L, Horvath LG, Pasam A, Tolmeijer SH, Akhurst TJ, Alipour R, Banks P, Buteau JP, Cassidy E, Crumbaker M, Dhiantravan N, Xu W, Chan J, Hitchen N, Scalzo M, Ravi Kumar AS, Kong G, Wallace R, Williams N, Williams S, Haynes NM, Neeson P, Wyatt AW, Hicks RJ, Hofman MS. [177Lu]Lu-PSMA-617 in combination with pembrolizumab for treatment of metastatic castration resistant prostate cancer (PRINCE): a single-arm, phase 1b/2 study. Lancet Oncol. 2026 Apr;27(4):470-479. doi: 10.1016/S1470-2045(26)00017-3.
• Kashyap R, Buteau JP, Bressel M, Eifer M, Bollampally N, Jackson P, McIntosh L, Sandhu S, Hofman MS. Prognostic Value of Posttherapy SPECT/CT for Overall Survival in Patients Undergoing [177Lu]Lu-PSMA-617 Radiopharmaceutical Therapy: Results from 3 Clinical Trials. J Nucl Med. 2025 Aug 1;66(8):1265-1270. doi: 10.2967/jnumed.125.269640.

Drugs

Indications