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Measurement of safety limit of radionuclide therapy in treatment of patients with prostate cancer

Post-therapeutic dosimetry of 177Lu-DKFZ-PSMA-617 in treatment of patients with castration resistant prostate cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/006998
Enrollment
50
Registered
2016-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- prostate cancer patients who have failed hormonal and chemotherapy

Interventions

Intervention1: 177Lu PSMA 617 radionuclide therapy: Radiopharmaceutical 177LuCl3 obtained from BARC PSMA 617 obtained from ABX Germany Intervention2: lutetium prostate specific membrane antigen radio

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Studying the pharmacokinetics and dosimetry of 177Lu-PSMA-617 in CRPC patients.Timepoint: 7 days

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr C S Bal

All India Institute of Medical Sciences

madhavyadav44@gmail.com9650857758

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026