Comparison of targeted 225Ac-PSMA-617 alpha particle therapy versus177Lu-PSMA-617 beta particle therapy in metastatic castration resistant prostate cancerpatients: An open-label, two-arm, phase II RCT

All India Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

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•Patients with histologically or cytologically confirmed adenocarcinoma of prostate.
•Patients with disease progression in spite of androgen deprivation therapy or
•chemotherapy.
•Surgically or medically castrated
•68Ga-PSMA PET/CT showing sites of PSMA expressing disease
•Patients ECOG performance status <= 3
•Patients Karnofsky performance status of >= 60
•Patients with GFR level >= 60 ml/min
•Normal KFT( Kidney Function Test) and LFT (Liver Function Test)•
•At least four weeks gap between prior surgery or radiotherapy

•Negative 68Ga-PSMA PET/CT scan or bone scan
•History of pituitary or adrenal dysfunction
•Anticipated life expectancy of less than 6 months
•Patients with history of prior cardiac disease
•Abnormal amino transferase levels;
•More than 2.5 times the upper value of the normal rangesin patients without liver
•Less than 5 times the upper value of the normal range in patients with known liver
•Active or symptomatic viral hepatitis or chronic liver disease patients
•History of a different malignancy except for the following circumstances: diseasefree survival for at least 5 years and deemed by the investigator to b at low-risk for recurrence
•of that malignancy.
•Patients not giving written informed consent

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