Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study
Summary
Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before. In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time. The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects. The performance of different prostate cancer diagnostic methods is also in scope of the study.
Timeline
- Start
- 2024-02-20
- Primary completion
- 2028-06
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 161Tb-SibuDAB | Unknown | 200 ug | Intravenous |
| Comparator | 161Tb-SibuDAB | Unknown | 1000 mbq | Intravenous |
| Comparator | 177Lu-PSMA-I&T | Other / unclassified | 100 ug | Intravenous |
| Comparator | 177Lu-PSMA-I&T | Other / unclassified | 1000 mbq | Intravenous |