We recently published the first dosimetry data, to our knowledge, for the radioligand therapy agent 177Lu-rhPSMA-10.1, providing an intrapatient comparison with 177Lu-PSMA-I&T in patients with metastatic prostate cancer. Here, we report efficacy and safety findings from these patients. Methods: Four consecutive patients with prostate-specific membrane antigen (PSMA)-positive metastatic prostate cancer received up to 6 cycles of 177Lu-rhPSMA-10.1 (7.4-7.7 GBq per cycle). Efficacy (prostate-specific antigen response according to Prostate Cancer Working Group 3 criteria and the Response Evaluation Criteria in PSMA PET/CT), progression-free survival, and overall survival were evaluated. Adverse events were recorded from the first dose until 16-24 mo after treatment. Results: The patients received a total activity of 29.6-59.4 GBq (4-6 cycles). Prostate-specific antigen was reduced by 100%, 99%, 88%, and 35%. Progression-free survival was not reached for 2 patients at 24 and 18 mo of follow-up and was 15 and 12 mo for the other 2 patients. One patient had a sustained complete response with 2 y of follow up. All patients were alive at the last time point of data collection. No serious adverse events were reported. Conclusion: 177Lu-rhPSMA-10.1 demonstrated encouraging preliminary efficacy and was well tolerated. Formal clinical trials are now under way to evaluate its potential prospectively (NCT05413850).
Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2023 Dec 21 [Epub ahead of print]
Alexander Dierks, Alexander Gäble, Andreas Rinscheid, Georgine Wienand, Christian H Pfob, Malte Kircher, Johanna S Enke, Tilman Janzen, Marianne Patt, Martin Trepel, Dorothea Weckermann, Ralph A Bundschuh, Constantin Lapa
Nuclear Medicine, Faculty of Medicine, University of Augsburg, Augsburg, Germany., Medical Physics and Radiation Protection, University Hospital Augsburg, Augsburg, Germany., Internal Medicine and Oncology, Faculty of Medicine, University of Augsburg, Augsburg, Germany; and., Urology, Faculty of Medicine, University of Augsburg, Augsburg, Germany., Nuclear Medicine, Faculty of Medicine, University of Augsburg, Augsburg, Germany; .