EBRT + Lu-PSMA for N1M0 Prostate Cancer
Summary
The PROQURE project aims to provide prostate cancer patients with more cure and better quality of life. The first part of this project (PROQURE-1) aims to explore an innovative combined modality treatment strategy for patients with node-positive prostate cancer (N1M0). The current standard of care for these patients, external beam radiotherapy (EBRT) of the prostate and regional pelvic nodes combined with 2-3 years androgen deprivation therapy (ADT), leads to suboptimal tumor control while inducing significant and potentially persistent toxicity. To overcome this, the current locoregional treatment is complemented with systemic Lutetium-177-PSMA radioligand therapy in a phase I study, with the aim to achieve better tumor control while potentially reducing or obviating ADT and its associated toxicity for future patients.
Timeline
- Start
- 2021-12-20
- Primary completion
- 2025-09-09
- Completion
- 2025-09-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-PSMA-617 | Other / unclassified | 3000 mbq | Intravenous |
| Subject | 177Lu-PSMA-617 | Other / unclassified | 6000 mbq | Intravenous |
| Subject | 177Lu-PSMA-617 | Other / unclassified | 7400 mbq | Intravenous |
| Subject | 177Lu-PSMA-617 | Other / unclassified | 9000 mbq | Intravenous |