drugset / Trial / NCT05162573

EBRT + Lu-PSMA for N1M0 Prostate Cancer

NCT05162573

Non-randomizedSequentialOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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

Indications