PT  - JOURNAL ARTICLE
AU  - Kambiz Rahbar
AU  - Hojjat Ahmadzadehfar
AU  - Clemens Kratochwil
AU  - Uwe Haberkorn
AU  - Michael Schäfers
AU  - Markus Essler
AU  - Richard P. Baum
AU  - Harshad R. Kulkarni
AU  - Matthias Schmidt
AU  - Alexander Drzezga
AU  - Peter Bartenstein
AU  - Andreas Pfestroff
AU  - Markus Luster
AU  - Ulf Lützen
AU  - Marlies Marx
AU  - Vikas Prasad
AU  - Winfried Brenner
AU  - Alexander Heinzel
AU  - Felix M. Mottaghy
AU  - Juri Ruf
AU  - Philipp Tobias Meyer
AU  - Martin Heuschkel
AU  - Maria Eveslage
AU  - Martin Bögemann
AU  - Wolfgang Peter Fendler
AU  - Bernd Joachim Krause
TI  - German Multicenter Study Investigating <sup>177</sup>Lu-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients
AID  - 10.2967/jnumed.116.183194
DP  - 2017 Jan 01
TA  - Journal of Nuclear Medicine
PG  - 85--90
VI  - 58
IP  - 1
4099  - http://jnm.snmjournals.org/content/58/1/85.short
4100  - http://jnm.snmjournals.org/content/58/1/85.full
SO  - J Nucl Med2017 Jan 01; 58
AB  - 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 of 177Lu-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 with 177Lu-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. 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.