TY - JOUR T1 - <strong><sup>177</sup></strong><strong>Lu-DKFZ-PSMA-617 </strong><strong>therapy in metastatic castration resistant prostate cancer: safety, efficacy and quality of life assessment</strong> JF - Journal of Nuclear Medicine JO - J Nucl Med SP - 524 LP - 524 VL - 59 IS - supplement 1 AU - Madhav Yadav AU - Sanjana Ballal AU - Madhavi Tripathi AU - Nishikant Damle AU - Chandrasekhar Bal Y1 - 2018/05/01 UR - http://jnm.snmjournals.org/content/59/supplement_1/524.abstract N2 - 524Objectives: The objective of this study was to evaluate the efficacy and safety of a novel theranostic agent, 177Lu-DKFZ-PSMA-617 therapy in metastatic castration resistant prostate cancer (mCRPC). Methods: 56 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-CCPET/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), Karanofskys performance status (KPS) and Toxicity and response criteria of the Eastern Cooperative Oncology Group (ECOG) criteria. Results: The mean age of patients was 66.94 ± 9.4 years (range: 38-81 years). The mean activity administered in the 46 patients was 5977 ± 1845 MBq ranging from 2-6 cycles. There was a decline in the mean serum PSA levels from the baseline (baseline: 387 ng/ml, post 1st cycle therapy: 192.75 ng/ml). Based on biochemical response criteria 4/56, 29/56, 11/56 and 12/56 had complete response (CR), partial response(PR), stable disease (SD) and progressive disease (PD), respectively. Metabolic response revealed 4/13 patients with near CR, 4/13 patients with PR, 3/13 patients with SD and 2/13 with PD. The mean VASmax score decreased from 7.5 to 3. The mean analgesic score reduced from 2.5 to 1.7 after therapy. The mean KPS score improved from 32 to 65.42 after therapies. The mean ECOG performance status improved from 2.5 to 1.75 after therapy. Two patients experienced grade I and grade II hemoglobin toxicity each. None of the patients experienced nephrotoxicity or hepatotoxicity. Conclusions: 177Lu-DKFZ-PSMA-617 radionuclide therapy is a safe and effective approach in the treatment of mCRPC patients. ER -