title: Systemic Radioligand Therapy with (177)Lu Labeled Prostate Specific Membrane Antigen Ligand for Imaging and Therapy in Patients with Metastatic Castration Resistant Prostate Cancer.
abstract: We report our initial clinical experience with β -emitting (177)Lu-PSMA-I&T ((177)Lu labeled prostate specific membrane antigen ligand for imaging and therapy) for systemic treatment of metastatic castration resistant prostate cancer.
  
  
  
  Patients with metastatic castration resistant prostate cancer who experienced treatment failure with chemotherapy and novel androgen receptor targeted therapy were treated for 8 weeks with up to 4 cycles of (177)Lu-PSMA-I&T. We report safety data, the antitumor response with prostate specific antigen decreases and the radiographic tumor response as well as the clinical outcome with changes in ECOG (Eastern Cooperative Oncology Group) performance status and pain severity.
  
  
  
  The first 3 patients were treated with a lower activity of 3.7 GBq in cycle 1. Due to a favorable safety profile the activity was increased to 7.4 GBq in 19 subsequent patients who completed a total of 40 cycles. With the higher activity no grade 3/4 toxicities were observed. The main nonhematological and hematological grade 1/2 toxicities were dry mouth in 7 patients (37%), anemia in 6 (32%) and thrombopenia in 5 (25%). The proportion of patients who achieved a maximum prostate specific antigen decrease of 30% or greater, 50% or greater and 90% or greater was 56%, 33% and 11%, respectively. Combined assessment of bone and soft tissue metastases showed complete remission in 5% of patients, stable disease in 63% and progressive disease in 32%. ECOG performance status improved or was stable in 74% of patients. Of men with bone pain 58% achieved complete resolution or reduced pain.
  
  
  
  Radioligand therapy with (177)Lu-PSMA-I&T appears to be safe and active in heavily pretreated patients with metastatic castration resistant prostate cancer.
authors.affiliation: Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. Electronic address: matthias.heck@tum.de.
authors.forename: Matthias M
authors.initials: MM
authors.lastname: Heck
authors.affiliation: Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Margitta
authors.initials: M
authors.lastname: Retz
authors.affiliation: Department of Nuclear Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Calogero
authors.initials: C
authors.lastname: D'Alessandria
authors.affiliation: Department of Nuclear Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Isabel
authors.initials: I
authors.lastname: Rauscher
authors.affiliation: Department of Nuclear Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Klemens
authors.initials: K
authors.lastname: Scheidhauer
authors.affiliation: Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Maurer
authors.affiliation: Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Enno
authors.initials: E
authors.lastname: Storz
authors.affiliation: Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany; Department of Nuclear Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Friederike
authors.initials: F
authors.lastname: Janssen
authors.affiliation: Pharmaceutical Radiochemistry, Technical University of Munich, Garching, Germany.
authors.forename: Margret
authors.initials: M
authors.lastname: Schottelius
authors.affiliation: Pharmaceutical Radiochemistry, Technical University of Munich, Garching, Germany.
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Wester
authors.affiliation: Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Jürgen E
authors.initials: JE
authors.lastname: Gschwend
authors.affiliation: Department of Nuclear Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Schwaiger
authors.affiliation: Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Tauber
authors.affiliation: Department of Nuclear Medicine, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Eiber
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000532:radiotherapy*; D000368:Aged; D000954:Antigens, Surface / Q000627:therapeutic use*; D043425:Glutamate Carboxypeptidase II / Q000627:therapeutic use*; D006801:Humans; D008024:Ligands; D008187:Lutetium / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D064129:Prostatic Neoplasms, Castration-Resistant / Q000473:pathology / Q000532:radiotherapy*; D011868:Radioisotopes / Q000627:therapeutic use*; D019275:Radiopharmaceuticals / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000954:Antigens, Surface; D008024:Ligands; D011868:Radioisotopes; D019275:Radiopharmaceuticals; D008187:Lutetium; C000615061:Lutetium-177; C473848:FOLH1 protein, human; D043425:Glutamate Carboxypeptidase II
keywords: castration; glutamate carboxypeptidase II, human; lutetium; neoplasm metastasis; prostatic neoplasms