THERAPEUTIC EFFICACY OF ABIRATERONE ACETATE VERSUS CONCOMITANT 177LU-DKFZ-PSMA-617 AND ABIRATERONE ACETATE THERAPY IN PATIENTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER: OPEN LABEL, TWO-ARM, PHASE II TRIA

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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•1. Patients with histologically or cytologically confirmed adenocarcinoma of prostate.
•2. Patients with disease progression in spite of androgen deprivation therapy or chemotherapy.
•3. sPSA > 5ng/ml
•4. Surgically or medically castrated
•5. 68Ga-PSMA PET/CT showing sites of PSMA expressing disease
•6. Patients ECOG performance status <= 3
•7. Patients Karnofsky performance status of >= 60
•8. Patients with GFR level >= 60 ml/min
•9. Heamoglobin >= 9.5 gm/dL
•10. Platelet count >150,000 cells/mm3
•11. WBC count >4000/cu.mm
•12. Normal KFT( Kidney Function Test) and LFT (Liver Function Test)
•13. Willing to take abiraterone on an empty stomach
•14. No previous history of prior radionuclide therapy
•15. At least four weeks gap between prior surgery or radiotherapy

•1. Negative Ga68-PSMA scan or bone scan
•2. Known allergies, hypersensitivity or intolerance to abiraterone acetate prednisone or their excipients
•3. Uncontrolled hypertension
•4. Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose.
•5.History of pituitary or adrenal dysfunction
•6. Bicalutamide, nilutamide within 6 weeks of cycle 1, day 1
•7. Anticipated life expectancy of less than 6 months
•8. Patients with history of prior cardiac disease
•9. Abnormal amino transferase levels;
•> 2.5 times the upper value of the normal rangesin patients without liver metastases
•< 5 times the upper value of the normal range in patients with known liver metastasis
•10. Active or symptomatic viral hepatitis or chronic liver disease patients
•11. History of a different malignancy except for the following circumstances: disease-free survival for at least 5 years and deemed by the investigator to b at low-risk for recurrence of that malignancy.
•12. Patients not giving written informed consent

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