drugset / Trial / NCT05867615
Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:
Phase 2
Active not recruiting
83 enrolled
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
NaSingle-groupOpen-labelTreatment
Summary
Phase 2 study, single arm trial enrolling patients with a Gallium-68/Fluorine-18 prostate-specific membrane antigen (PSMA) positive positron emission tomography/Computed Tomography (PET/CT) in order to be treated with Lutetium-177 (177Lu) PSMA. Patients without risk factors for toxicity will receive 7.4 GBq of 177Lu-PSMA while patients with at least 1 risk factor for toxicity will receive 5.5 GBq of 177Lu-PSMA. Patients will receive 4 cycles every 8 weeks (+- 2 weeks)
Timeline
- Start
- 2023-05-25
- Primary completion
- 2026-08
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LUTETIUM LU 177 ZADAVOTIDE GURAXETAN | Other / unclassified | 5500 mbq | Intravenous |
| Subject | LUTETIUM LU 177 ZADAVOTIDE GURAXETAN | Other / unclassified | 7400 mbq | Intravenous |