Health Condition 1: null- prostate cancer patients who have failed hormonal and chemotherapy
Conditions
Interventions
Intervention1: 177Lu-PSMA-617 radionuclide therapy: 177LuCl3 is obtained from Bhaba atomic research
centre PSMA-617 is obtained from ABX, Germany.
we label both the above compounds in our
laboratory.
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: follow-up of all patients every quarterly | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria) â?¢ Progression-free survival according to radiologic findings based on pre-specified criteria, and the PSA response rate â?¢ Objective responseTimepoint: follow-up of all patients every quarterly | — |
Countries
India
Contacts
Public ContactChandrasekhar Bal
All India Institute of Medical Sciences
Outcome results
None listed