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OtherClinical Investigations (Human)

German multicenter study investigating 177Lu-PSMA-617 radioligand therapy in advanced prostate cancer patients

Kambiz Rahbar, Hojjat Ahmadzadehfar, Clemens Kratochwil, Uwe Haberkorn, Michael Schäfers, Markus Essler, Richard P Baum, Harshad R Kulkarani, Matthias Schmidt, Peter Bartenstein, Andreas Pfestroff, Ulf Lützen, Marlies Marx, Vikas Prasad, Winfried Brenner, Alexander Heinzel, Juri Ruf, Philipp Tobias Meyer, Martin Heuschkel, Maria Eveslage, Martin Bögemann, Wolfgang Peter Fendler and Bernd Joachim Krause
Journal of Nuclear Medicine October 2016, jnumed.116.183194; DOI: https://doi.org/10.2967/jnumed.116.183194
Kambiz Rahbar
1 Department of Nuclear Medicine, University Hospital Muenster, Germany;
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Hojjat Ahmadzadehfar
2 Department of Nuclear Medicine, University Hospital Bonn, Germany;
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Clemens Kratochwil
3 University Hospital of Heidelberg, Germany;
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Uwe Haberkorn
4 University Hospital Heidelberg, Germany;
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Michael Schäfers
1 Department of Nuclear Medicine, University Hospital Muenster, Germany;
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Markus Essler
5 Department of Nuclear Medicine, University Hospital, Germany;
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Richard P Baum
6 Theranostics Center for Molecular Radiotherapy and Molecular Imaging, Germany;
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Harshad R Kulkarani
6 Theranostics Center for Molecular Radiotherapy and Molecular Imaging, Germany;
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Matthias Schmidt
7 Department of Nuclear Medicine, University Hospital Cologne, Germany;
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Peter Bartenstein
8 Department of Nuclear Medicine, Ludwig-Maximilians-University Munich, Germany;
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Andreas Pfestroff
9 Department of Nuclear Medicine, Universe of Marburgl, Germany;
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Ulf Lützen
10 Department of Nuclear Medicine, University of Schleswig-Holstein, Germany;
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Marlies Marx
10 Department of Nuclear Medicine, University of Schleswig-Holstein, Germany;
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Vikas Prasad
11 Department of Nuclear Medicine, Charite, University Hospital Berlin, Germany;
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Winfried Brenner
11 Department of Nuclear Medicine, Charite, University Hospital Berlin, Germany;
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Alexander Heinzel
12 Department of Nuclear Medicine, University Hospital Aachen, Germany;
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Juri Ruf
13 Department of Nuclear Medicine, University of Freiburg, Germany;
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Philipp Tobias Meyer
13 Department of Nuclear Medicine, University of Freiburg, Germany;
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Martin Heuschkel
14 Department of Nuclear Medicine, University of Rostock, Germany;
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Maria Eveslage
15 Institute of Biostatistics and Clinical Research, University of Muenster, Germany;
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Martin Bögemann
16 Department of Urology, University Hospital Muenster, Germany;
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Wolfgang Peter Fendler
8 Department of Nuclear Medicine, Ludwig-Maximilians-University Munich, Germany;
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Bernd Joachim Krause
17 German Society of Nuclear Medicine, Germany
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Abstract

177Lutetium labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castration resistant prostate cancer (mCRPC). Initiated by the German Society of Nuclear Medicine a retrospective multicenter data analysis was started in 2015 to evaluate efficacy and safety of 177Lu-PSMA-617 in a large cohort of patients. Methods: 145 patients (median age 73 years, range 43-88) with mCRPC were treated with 177Lu-PSMA-617 in 12 therapy centres between February 2014 and July 2015 with one to four therapy cycles and an activity range of 2 to 8 GBq per cycle. Toxicity was categorized by the common toxicity criteria for adverse events (CTCAE 4.0) based on serial blood tests and the attending physician’s report. Primary endpoint for efficacy was biochemical response as defined by a PSA decline ≥ 50% from baseline to at least two weeks after start of RLT. Results: A total of 248 therapy cycles were performed in 145 patients. Data for biochemical response were available in 99 patients and data for physician-reported/lab-based toxicity in 145/121 patients. The median follow-up was 16 weeks (range 2-30 weeks). Nineteen patients died during the observation period. Grade 3 to 4 hematotoxicity occurred in 18 patients: 10%, 4% and 3% of the patients experienced anemia, thrombocytopenia and leukopenia, respectively. Xerostomia occurred in 8%. Overall biochemical response rate was 45% following all therapy cycles, while 40% of patients already responded after a single cycle. Elevated alkaline phosphatase and presence of visceral metastases were negative predictors and the total number of therapy cycles positive predictors of biochemical response. Conclusion: The present retrospective multicenter study of 177Lu-PSMA-617 RLT demonstrates favorable safety and high efficacy exceeding those of other third line systemic therapies in mCRPC patients. Future Phase II/III studies are warranted to elucidate the survival benefit of this new therapy in patients with mCRPC.

  • Genitourinary
  • Oncology: GU
  • Radionuclide Therapy
  • PSMA-617
  • Prostate cancer
  • Radioligand therapy
  • mCRPC
  • Copyright © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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Journal of Nuclear Medicine: 64 (9)
Journal of Nuclear Medicine
Vol. 64, Issue 9
September 1, 2023
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German multicenter study investigating 177Lu-PSMA-617 radioligand therapy in advanced prostate cancer patients
Kambiz Rahbar, Hojjat Ahmadzadehfar, Clemens Kratochwil, Uwe Haberkorn, Michael Schäfers, Markus Essler, Richard P Baum, Harshad R Kulkarani, Matthias Schmidt, Peter Bartenstein, Andreas Pfestroff, Ulf Lützen, Marlies Marx, Vikas Prasad, Winfried Brenner, Alexander Heinzel, Juri Ruf, Philipp Tobias Meyer, Martin Heuschkel, Maria Eveslage, Martin Bögemann, Wolfgang Peter Fendler, Bernd Joachim Krause
Journal of Nuclear Medicine Oct 2016, jnumed.116.183194; DOI: 10.2967/jnumed.116.183194

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German multicenter study investigating 177Lu-PSMA-617 radioligand therapy in advanced prostate cancer patients
Kambiz Rahbar, Hojjat Ahmadzadehfar, Clemens Kratochwil, Uwe Haberkorn, Michael Schäfers, Markus Essler, Richard P Baum, Harshad R Kulkarani, Matthias Schmidt, Peter Bartenstein, Andreas Pfestroff, Ulf Lützen, Marlies Marx, Vikas Prasad, Winfried Brenner, Alexander Heinzel, Juri Ruf, Philipp Tobias Meyer, Martin Heuschkel, Maria Eveslage, Martin Bögemann, Wolfgang Peter Fendler, Bernd Joachim Krause
Journal of Nuclear Medicine Oct 2016, jnumed.116.183194; DOI: 10.2967/jnumed.116.183194
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Keywords

  • Genitourinary
  • Oncology: GU
  • Radionuclide Therapy
  • PSMA-617
  • prostate cancer
  • radioligand therapy
  • mCRPC
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