Clinical Trial Protocol for LuTectomy: A Single-arm Study of the Dosimetry, Safety, and Potential Benefit of Lu-177-PSMA-617 Prior to Prostatectomy
Nattakorn Dhiantravan, John Violet, Renu Eapen, Omar Alghazo, Mark Scalzo, Price Jackson, Simon P Keam, Catherine Mitchell, Paul J Neeson, Shahneen Sandhu, Scott G Williams, Daniel Moon, Nathan Lawrentschuk, Arun Azad, Michael S Hofman, Declan G Murphy
EUROPEAN UROLOGY FOCUS | ELSEVIER | Published : 2021
LuTectomy is an open-label phase 1/2 nonrandomised clinical trial evaluating the dosimetry, efficacy, and toxicity of the lutetium-177-radiolabelled small molecule PSMA-617 in men with high-risk localised/locoregional advanced prostate cancer with high prostate-specific membrane antigen expression who are undergoing radical prostatectomy and pelvic lymph node dissection.
We thank Annette Van Der Heyden, ProsTIC Programme Manager, and Dr. Rebecca Loh, Clinical Trials Co-ordinator. We also thank the Australasian Radiopharmaceutical Trials Network (ARTnet) for contributing to radiopharmaceutical and PET camera quality control parameters. Dr. Nattakorn Dhiantravan is a recipient of The RACP Arnott Research Entry Scholarship in Cancer Research. The study also receives support from Prostate Cancer Foundation (PCF) ProsTIC funding. Professor Michael S. Hofman is funded by PCF as Director of ProsTIC. The study is funded by the Movember Foundation/Medical Research Future Fund (MRFF) Prostate Cancer Research Alliance and the EJ Whitten Prostate Cancer Research Centre, Epworth Healthcare, Australia. LuTectomy is sponsored by the Peter MacCallum Cancer Centre. Endocyte, now a Novartis company, provided PSMA-617 supply and financial support.