Long-Term Follow-up and Outcomes of Retreatment in an Expanded 50-Patient Single-Center Phase II Prospective Trial of Lu-177-PSMA-617 Theranostics in Metastatic Castration-Resistant Prostate Cancer
John Violet, Shahneen Sandhu, Amir Iravani, Justin Ferdinandus, Thang Sue-Ping, Grace Kong, Aravind Ravi Kumar, Tim Akhurst, David Pattison, Alexis Beaulieu, Jennifer Mooi, Ben Tran, Christina Guo, Victor Kalff, Declan G Murphy, Price Jackson, Peter Eu, Mark Scalzo, Scott G Williams, Rod J Hicks Show all
Journal of Nuclear Medicine | SOC NUCLEAR MEDICINE INC | Published : 2020
177Lu-PSMA-617 is a radioligand with high affinity for prostate-specific membrane antigen (PSMA), enabling targeted β-irradiation of prostate cancer. We have previously reported favorable activity with low toxicity in a prospective phase II trial involving 30 men with metastatic castration-resistant prostate cancer. We now report their longer-term outcomes, including a 20-patient extension cohort and outcomes of subsequent systemic treatments after completion of trial therapy. Methods: Fifty patients with PSMA-avid metastatic castration-resistant prostate cancer who had progressed after standard therapies received up to 4 cycles of 177Lu-PSMA every 6 wk. Endpoints included prostate-specific ..View full abstract
177Lu (no carrier added) was supplied by the Australian Nuclear Science and Technology Organization (ANSTO, Sydney, Australia), and PSMA-617 was supplied by Advanced Biochemical Compounds (ABX, Radeberg, Germany) and subsequently Endocyte (now part of Advanced Accelerator Applications, a Novartis company). Interim results of this study were presented at the 2019 ASCO Genitourinary Symposium (San Diego) and the 2018 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (Philadelphia). Michael Hofman is the chair of the ANZUP TheraP Study, which receives research support from the Prostate Cancer Foundation of Australia (PCFA), Endocyte (a Novartis company), and the Australian Nuclear Science and Technology Organisation (ANSTO, Sydney, Australia). Michael Hofman additionally receives research support from Movember Australia, the Prostate Cancer Foundation (PCF), the Prostate Cancer Foundation of Australia (PCFA), and the Victoria Cancer Agency (VCA). Unrelated to this work, he has received honoraria and travel support for educational lectures from Janssen, Ipsen, and Sanofi Genzyme. Rodney Hicks holds shares in Telix on behalf of the Peter MacCallum Cancer Centre and has received travel support from GE Medical Systems and Siemens Healthineers. Ben Tran receives consulting and honoraria from Amgen, Astellas, Bayer, Bristol-Myers Squibb, IQVIA, Janssen-Cilag, Sanofi, Novartis, and Ipsen and research funding from Amgen and Astellas. Michael Hofman and Shahneen Sandhu receive from the Peter MacCallum Foundation a Clinical Fellowship directly supporting this research. No other potential conflict of interest relevant to this article was reported.