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A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T Versus Hormone Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I\&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer.
Details
| Lead sponsor | Curium US LLC |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 439 |
| Start date | 2022-02-14 |
| Completion | 2029-02 |
Conditions
- Metastasis From Malignant Tumor of Prostate
Interventions
- 177Lu-PSMA-I&T
- Abiraterone with Prednisone or Enzalutamide
Primary outcomes
- Radiographic Progression Free Survival — 34 weeks
Radiographic progression free survival (rPFS), defined as the time from randomization to radiographic progression (using PCWG3 and RECIST 1.1 criteria as assessed by blinded independent central review \[BICR\]) or death due to any cause.
Countries
United States, France, Italy, Spain