Measurement of safety limit of radionuclide therapy in treatment of patients with prostate cancer
Phase 4
- Conditions
- Health Condition 1: null- prostate cancer patients who have failed hormonal and chemotherapy
- Registration Number
- CTRI/2016/06/006998
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Patients with histologically proven prostate cancer who have been treated by either surgery or radiotherapy and antiandrogen therapy
First line or Second line therapy for CRPC given but rising PSA
sPSA greater than 5ng per ml
Ga68 PSMA showing sites of PSMA expressing disease
Normal Kidney Function Test and Liver Function Test
Karnofsky performance status greater than 60
Patients with GRF level greater than 60 ml per min
Exclusion Criteria
Negative Ga68 PSMA scan
Coexisting second malignancies
Patients with
Hbless than 11 gm percent
Platelet count less than 150000 per cumm
TLC less than 4000 per cumm
Serum Creatinine greater than 1.3 mg percent
Anticipated life expectancy of less than 3 months
Patients who refuse written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Studying the pharmacokinetics and dosimetry of 177Lu-PSMA-617 in CRPC patients.Timepoint: 7 days
- Secondary Outcome Measures
Name Time Method Therapeutic outcome of 177 Lu-PSMA-617 in these patients would be evaluated using PSA and clinical response criteriaTimepoint: follow-up of all patients every quarterly