RT Journal Article SR Electronic T1 A long-term outcome study on 177Lu-PSMA-617 Radioligand Therapy in metastatic castration Resistant Prostate Cancer: Single-institutional Results JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP 463 OP 463 VO 60 IS supplement 1 A1 Madhav Yadav A1 Sanjana Ballal A1 Ranjit Sahoo A1 Madhavi Tripathi A1 Nishikant Damle YR 2019 UL http://jnm.snmjournals.org/content/60/supplement_1/463.abstract AB 463Objectives: The objective of this study was to evaluate the safety and efficacy of 177Lu-DKFZ-PSMA-617 therapy in metastatic castration resistant prostate cancer (mCRPC). Methods: In this prospective, single-arm, single-institutional study, 90 mCRPC patients with progressive disease despite second-line hormonal therapy and/or Docetaxel chemotherapy were recruited for the study. All patients underwent diagnostic 68Ga-PSMA-HBED-CC PET/CT, prior to inclusion for therapy. Included patients underwent quarterly 177Lu-DKFZ-PSMA-617 therapy. Hematological, kidney function, liver function tests, and serum PSA levels were recorded before and after therapy at 2 weeks, 4 weeks and 3-month intervals. Biochemical response was assessed using trend in serum PSA levels. Metabolic response was assessed by PERCIST 1 criteria. Clinical response was assessed by visual analogue score (VASmax), analgesic score (AS), Karnofsky performance status (KPS) and Toxicity and response criteria of the Eastern Cooperative Oncology Group (ECOG) criteria. Kaplan-Meier survival curves were used to derive, overall and progression-free survival. Results: The median age of patients was 66.5 years (range: 30-88 years). The median activity administered in the 90 patients was 111 ± 60.6 GBq ranging from 1-7cycles. Three patients experienced grade I and grade II hemoglobin toxicity each. None of the patients experienced grade 3 or 4 nephrotoxicities or hepatotoxicity. At 2-3 month interval after the first therapy, >80% decline in PSA was observed in 11.1%, >50-79 % decline in 20 %, >25%-50% decline in 24.5% , and < 25% decline in 6.7 %. Similarly <25% increase in PSA was observed in 13.3 % and >25% increase in 24.4%. Molecular tumor response by PERCIST 1 criteria revealed 19/69 (27.5%) patients with PR, 30/69 (43.5%) with SD, and 20/69 (29%) with PD. The median overall survival and median progression-free survivals were 14 and 11.8 months, respectively. The mean VASmax score decreased from 8 to 5. The mean analgesic score reduced from 3 to 2 after therapy. The mean KPS score improved from 60 to 70 after therapies. The mean ECOG performance status improved from 3 to 2 after therapy. Conclusions: 177Lu-DKFZ-PSMA-617 radionuclide therapy is a safe and effective approach to the treatment of mCRPC patients.