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OtherClinical Investigations (Human)

First clinical results for PSMA targeted alpha therapy using 225Ac-PSMA-I&T in advanced mCRPC patients

Mathias Johannes Zacherl, Franz Josef Gildehaus, Lena Mittlmeier, Guido Boening, Astrid Gosewisch, Vera Wenter, Nina-Sophie Schmidt-Hegemann, Claus Belka, Alexander Kretschmer, Jozefina Casuscelli, Christian G. Stief, Marcus Unterrainer, Peter Bartenstein, Andrei Todica and Harun Ilhan
Journal of Nuclear Medicine October 2020, jnumed.120.251017; DOI: https://doi.org/10.2967/jnumed.120.251017
Mathias Johannes Zacherl
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Franz Josef Gildehaus
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Lena Mittlmeier
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Guido Boening
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Astrid Gosewisch
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Vera Wenter
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Nina-Sophie Schmidt-Hegemann
2 Department of Radiation Oncology, University Hospital, LMU Munich, Germany;
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Claus Belka
2 Department of Radiation Oncology, University Hospital, LMU Munich, Germany;
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Alexander Kretschmer
3 Department of Urology, University Hospital, LMU Munich, Germany
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Jozefina Casuscelli
3 Department of Urology, University Hospital, LMU Munich, Germany
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Christian G. Stief
3 Department of Urology, University Hospital, LMU Munich, Germany
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Marcus Unterrainer
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Peter Bartenstein
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Andrei Todica
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Harun Ilhan
1 Department of Nuclear Medicine, University Hospital, LMU Munich, Germany;
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Abstract

Background: Treatment of advanced metastatic castration resistant prostate cancer (mCRPC) after failure of approved therapy options remains challenging. Prostate-specific membrane antigen (PSMA) targeting β- and α-emitters have been introduced with promising response rates. Here, we present the first clinical data for PSMA targeted α-therapy (TAT) using 225Ac-PSMA-I&T. Methods: 18 patients receiving 225Ac-PSMA-I&T have been included in this retrospective analysis. 15/18 had prior second line antiandrogen treatment with abiraterone and/or enzalutamide, 15/18 prior chemotherapy and 13/18 prior 177Lu-PSMA treatment. Patients were treated at bi-monthly intervals until progression or intolerable side effects. Prostate-specific antigen (PSA) was measured for response assessment. Hematological and non-hematological side effects were recorded according to CTCAE v5.0 criteria. Results: 38 cycles of 225Ac-PSMA-I&T were applied (median dose 7.8 MBq, range 6.0 – 8.5) with 1 cycle in 7/18, 2 cycles in 7/18, 4 cycles in 3/18 and 5 cycles in 1 patient. No acute toxicity was observed during hospitalization. Baseline PSA was 176 ng/ml (range 13.4 - 1146). 4/18 patients were excluded due to incomplete follow-up. Best PSA response after TAT with a PSA decline ≥ 50% was oberved in 7/14 patients. Any PSA decline was seen in 11/14 patients. 3 patients had no PSA decline at any time. A subgroup analysis of 11 patients with prior 177Lu-177-PSMA treatment showed any PSA decline in 8/11 and a PSA decline ≥ 50% in 5/11 patients. Therapy related adverse events included deteroriation from grade 1 anemia baseline to grade 2 and grade 3 anemia in 4/14 and 1/14 patients after TAT, respectively. Grade 3 leukopenia was observed in 1 patient. Newly diagnosed grade 1 and grade 2 xerostomia was observed in 2 and 3 patients, respectively. However, including pre-existing xerostomia after prior 177Lu-177 PSMA, 8/14 patients had grade 1 and 5/14 grade 2 xerostomia after TAT. No further grade 3/4 hematological or non-hematological toxicities were observed. Conclusion: Our first clinical data for TAT using 225Ac-PSMA-I&T showed promising antitumor effect in advanced mCRPC even after failure of prior 177Lu-PSMA treatment with tolerable side effects. These results are highly comparable to data on 225Ac-PSMA-617 TAT.

  • Oncology: GU
  • Radionuclide Therapy
  • 225Ac and 177Lu
  • PSMA
  • metastatic castration resistant prostate cancer
  • radioligand therapy
  • targeted alpha therapy
  • Copyright © 2020 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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Journal of Nuclear Medicine: 66 (6)
Journal of Nuclear Medicine
Vol. 66, Issue 6
June 1, 2025
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First clinical results for PSMA targeted alpha therapy using 225Ac-PSMA-I&T in advanced mCRPC patients
Mathias Johannes Zacherl, Franz Josef Gildehaus, Lena Mittlmeier, Guido Boening, Astrid Gosewisch, Vera Wenter, Nina-Sophie Schmidt-Hegemann, Claus Belka, Alexander Kretschmer, Jozefina Casuscelli, Christian G. Stief, Marcus Unterrainer, Peter Bartenstein, Andrei Todica, Harun Ilhan
Journal of Nuclear Medicine Oct 2020, jnumed.120.251017; DOI: 10.2967/jnumed.120.251017

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First clinical results for PSMA targeted alpha therapy using 225Ac-PSMA-I&T in advanced mCRPC patients
Mathias Johannes Zacherl, Franz Josef Gildehaus, Lena Mittlmeier, Guido Boening, Astrid Gosewisch, Vera Wenter, Nina-Sophie Schmidt-Hegemann, Claus Belka, Alexander Kretschmer, Jozefina Casuscelli, Christian G. Stief, Marcus Unterrainer, Peter Bartenstein, Andrei Todica, Harun Ilhan
Journal of Nuclear Medicine Oct 2020, jnumed.120.251017; DOI: 10.2967/jnumed.120.251017
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Cited By...

  • Deescalated 225Ac-PSMA-617 Versus 177Lu/225Ac-PSMA-617 Cocktail Therapy: A Single-Center Retrospective Analysis of 233 Patients
  • Development and Preclinical Evaluation of [211At]PSAt-3-Ga: An Inhibitor for Targeted {alpha}-Therapy of Prostate Cancer
  • Effectiveness of 225Ac-Labeled Anti-EGFR Radioimmunoconjugate in EGFR-Positive Kirsten Rat Sarcoma Viral Oncogene and BRAF Mutant Colorectal Cancer Models
  • Current Status of Prostate-specific Membrane Antigen-targeted Alpha Radioligand Therapy in Prostate Cancer
  • Clinical Experience with [225Ac]Ac-PSMA Treatment in Patients with [177Lu]Lu-PSMA-Refractory Metastatic Castration-Resistant Prostate Cancer
  • Dual-Time-Point Posttherapy 177Lu-PSMA-617 SPECT/CT Describes the Uptake Kinetics of mCRPC Lesions and Prognosticates Patients Outcome
  • Clinical Translation of Targeted {alpha}-Therapy: An Evolution or a Revolution?
  • Clinical Translation of Targeted {alpha}-Therapy: An Evolution or a Revolution?
  • Dosimetry in Radiopharmaceutical Therapy
  • Prostate-Specific Membrane Antigen Radioligand Therapy Using 177Lu-PSMA I&T and 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer: Comparison of Safety, Biodistribution, and Dosimetry
  • Effects of 225Ac-Labeled Prostate-Specific Membrane Antigen Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer: A Meta-Analysis
  • An Improved 211At-Labeled Agent for PSMA-Targeted {alpha}-Therapy
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More in this TOC Section

Clinical Investigations (Human)

  • The added value of 18F-FDG PET/CT compared to 68Ga-PSMA PET/CT in patients with castration-resistant prostate cancer
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Clinical (Oncology: GU)

  • Pretherapeutic Comparative Dosimetry of 177Lu-rhPSMA-7.3 and 177Lu-PSMA I&T in Patients with Metastatic Castration-Resistant Prostate Cancer
  • A Comparison of 18F-DCFPyL, 18F-NaF, and 18F-FDG PET/CT in a Prospective Cohort of Men with Metastatic Prostate Cancer
  • Detection of Additional Primary Neoplasms on 18F-Fluciclovine PET/CT in Patients with Primary Prostate Cancer
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Keywords

  • Oncology: GU
  • radionuclide therapy
  • 225Ac and 177Lu
  • PSMA
  • metastatic castration resistant prostate cancer
  • radioligand therapy
  • targeted alpha therapy
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