title: German Multicenter Study Investigating 177Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients.
abstract: 177Lu-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 of177Lu-PSMA-617 in a large cohort of patients.
  
  
  METHODS
  One hundred forty-five patients (median age, 73 y; range, 43-88 y) with mCRPC were treated with177Lu-PSMA-617 in 12 therapy centers between February 2014 and July 2015 with 1-4 therapy cycles and an activity range of 2-8 GBq per cycle. Toxicity was categorized by the common toxicity criteria for adverse events (version 4.0) on the basis of serial blood tests and the attending physician's report. The primary endpoint for efficacy was biochemical response as defined by a prostate-specific antigen decline ≥ 50% from baseline to at least 2 wk after the start of RLT.
  
  
  RESULTS
  A total of 248 therapy cycles were performed in 145 patients. Data for biochemical response in 99 patients as well as data for physician-reported and laboratory-based toxicity in 145 and 121 patients, respectively, were available. The median follow-up was 16 wk (range, 2-30 wk). Nineteen patients died during the observation period. Grade 3-4 hematotoxicity occurred in 18 patients: 10%, 4%, and 3% of the patients experienced anemia, thrombocytopenia, and leukopenia, respectively. Xerostomia occurred in 8%. The overall biochemical response rate was 45% after all therapy cycles, whereas 40% of patients already responded after a single cycle. Elevated alkaline phosphatase and the presence of visceral metastases were negative predictors and the total number of therapy cycles positive predictors of biochemical response.
  
  
  CONCLUSIONS
  The present retrospective multicenter study of177Lu-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.
authors.affiliation: Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany rahbar@uni-muenster.de.
authors.forename: Kambiz
authors.initials: K
authors.lastname: Rahbar
authors.affiliation: Department of Nuclear Medicine, University Hospital Bonn, Bonn, Germany.
authors.forename: Hojjat
authors.initials: H
authors.lastname: Ahmadzadehfar
authors.affiliation: Department of Nuclear Medicine, University of Heidelberg, Heidelberg, Germany.
authors.forename: Clemens
authors.initials: C
authors.lastname: Kratochwil
authors.affiliation: Department of Nuclear Medicine, University of Heidelberg, Heidelberg, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Haberkorn
authors.affiliation: Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Schäfers
authors.affiliation: Department of Nuclear Medicine, University Hospital Bonn, Bonn, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Essler
authors.affiliation: Theranostics Center for Molecular Radiotherapy and Molecular Imaging, Zentralklinik, Bad Berka, Bad Berka, Germany.
authors.forename: Richard P
authors.initials: RP
authors.lastname: Baum
authors.affiliation: Theranostics Center for Molecular Radiotherapy and Molecular Imaging, Zentralklinik, Bad Berka, Bad Berka, Germany.
authors.forename: Harshad R
authors.initials: HR
authors.lastname: Kulkarni
authors.affiliation: Department of Nuclear Medicine, University of Cologne, Cologne, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Schmidt
authors.affiliation: Department of Nuclear Medicine, University of Cologne, Cologne, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Drzezga
authors.affiliation: Department of Nuclear Medicine, Ludwig-Maximilians-University Munich, Munich, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bartenstein
authors.affiliation: Department of Nuclear Medicine, University of Marburg, Marburg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Pfestroff
authors.affiliation: Department of Nuclear Medicine, University of Marburg, Marburg, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Luster
authors.affiliation: Department of Nuclear Medicine, University of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Ulf
authors.initials: U
authors.lastname: Lützen
authors.affiliation: Department of Nuclear Medicine, University of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Marlies
authors.initials: M
authors.lastname: Marx
authors.affiliation: Department of Nuclear Medicine, Charite, University Hospital Berlin, Berlin, Germany.
authors.forename: Vikas
authors.initials: V
authors.lastname: Prasad
authors.affiliation: Department of Nuclear Medicine, Charite, University Hospital Berlin, Berlin, Germany.
authors.forename: Winfried
authors.initials: W
authors.lastname: Brenner
authors.affiliation: Department of Nuclear Medicine, University Hospital Aachen, Aachen, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Heinzel
authors.affiliation: Department of Nuclear Medicine, University Hospital Aachen, Aachen, Germany.
authors.forename: Felix M
authors.initials: FM
authors.lastname: Mottaghy
authors.affiliation: Department of Nuclear Medicine, University of Freiburg, Freiburg, Germany.
authors.forename: Juri
authors.initials: J
authors.lastname: Ruf
authors.affiliation: Department of Nuclear Medicine, University of Freiburg, Freiburg, Germany.
authors.forename: Philipp Tobias
authors.initials: PT
authors.lastname: Meyer
authors.affiliation: Department of Nuclear Medicine, University of Rostock, Rostock, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Heuschkel
authors.affiliation: Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany.
authors.forename: Maria
authors.initials: M
authors.lastname: Eveslage
authors.affiliation: Department of Urology, University Hospital Muenster, Muenster, Germany; and.
authors.forename: Martin
authors.initials: M
authors.lastname: Bögemann
authors.affiliation: Department of Nuclear Medicine, Ludwig-Maximilians-University Munich, Munich, Germany.
authors.forename: Wolfgang Peter
authors.initials: WP
authors.lastname: Fendler
authors.affiliation: Department of Nuclear Medicine, University of Rostock, Rostock, Germany.|German Society of Nuclear Medicine Göttingen, Göttingen, Germany.
authors.forename: Bernd Joachim
authors.initials: BJ
authors.lastname: Krause
mesh_terms: D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D015984:Causality; D015897:Comorbidity; D004151:Dipeptides / Q000627:therapeutic use*; D005858:Germany / Q000453:epidemiology; D006402:Hematologic Diseases / Q000453:epidemiology* / Q000517:prevention & control; D006573:Heterocyclic Compounds, 1-Ring / Q000627:therapeutic use*; D006801:Humans; D008187:Lutetium; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000453:epidemiology* / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000453:epidemiology* / Q000517:prevention & control; D019275:Radiopharmaceuticals / Q000627:therapeutic use; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: C000610110:Pluvicto; D004151:Dipeptides; D006573:Heterocyclic Compounds, 1-Ring; D019275:Radiopharmaceuticals; D008187:Lutetium; D017430:Prostate-Specific Antigen
keywords: PSMA-617; mCRPC; prostate cancer; radioligand therapy