title: 177Lu-DKFZ-PSMA-617 therapy in metastatic castration resistant prostate cancer: safety, efficacy, and quality of life assessment.
abstract: OBJECTIVE
  The purpose 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
  Thirty-one mCRPC patients with progressive disease despite second-line hormonal therapy and/or docetaxel chemotherapy were recruited for the study. All patients underwent diagnostic68Ga-PSMA-HBED-CCPET/CT, prior to inclusion for therapy. Included patients then underwent quarterly177Lu-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 with 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), Karanofsky performance status (KPS), and ttoxicity and response criteria of the Eastern Cooperative Oncology Group (ECOG) criteria.
  
  
  RESULTS
  The mean age of patients was 65.93 ± 9.77 years (range: 38-81 years). The mean activity administered in the 31 patients was 5069 ± 1845 MBq ranging from one to four cycles. There was a decline in the mean serum PSA levels from the baseline (baseline: 275 ng/mL, post 1st cycle therapy: 141.75 ng/mL). Based on biochemical response criteria 2/31, 20/31, 3/31, and 6/31 had complete response (CR), partial response(PR), stable disease (SD), and progressive disease (PD), respectively. Metabolic response revealed 2/6 patients with CR, and the remaining 3/6 patients with PR and 1/6 patients with SD. The mean VASmax score decreased from 7.5 to 3. The mean analgesic score decreased from 2.5 to 1.8 after therapy. The mean KPS score improved from 50.32 to 65.42 after therapies. The mean ECOG performance status improved from 2.54 to 1.78 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.
authors: Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.
authors: Madhav Prasad
authors: MP
authors: Yadav
authors: Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.
authors: Sanjana
authors: S
authors: Ballal
authors: Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.
authors: Madhavi
authors: M
authors: Tripathi
authors: Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.
authors: Nishikant Avinash
authors: NA
authors: Damle
authors: Department of Medical Oncology, BR Ambedkar Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.
authors: Ranjit Kumar
authors: RK
authors: Sahoo
authors: Department of Urology, All India Institute of Medical Sciences, New Delhi, India.
authors: Amlesh
authors: A
authors: Seth
authors: Department of Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India. csbal@hotmail.com.
authors: Chandrasekhar
authors: C
authors: Bal
mesh_terms: D000328:Adult; D000368:Aged; D004151:Dipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D006573:Heterocyclic Compounds, 1-Ring / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008187:Lutetium; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D017430:Prostate-Specific Antigen; D064129:Prostatic Neoplasms, Castration-Resistant / Q000175:diagnosis / Q000523:psychology* / Q000532:radiotherapy*; D011788:Quality of Life / Q000523:psychology*; D011832:Radiation Injuries / Q000209:etiology / Q000517:prevention & control; D019275:Radiopharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use; D000068936:Theranostic Nanomedicine / Q000379:methods; D016896:Treatment Outcome
chemical_list: C000603664:177Lu-DKFZ-617; C000610110:Pluvicto; D004151:Dipeptides; D006573:Heterocyclic Compounds, 1-Ring; D009942:Organometallic Compounds; D010455:Peptides; D019275:Radiopharmaceuticals; D008187:Lutetium; D017430:Prostate-Specific Antigen
keywords: 177Lu-DKFZ-PSMA-617 radionuclide therapy; Efficacy; Quality of life; mCRPC