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177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer

NCT05204927 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2025-07-31

No results posted yet for this study

Summary

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.

Conditions

  • Metastasis From Malignant Tumor of Prostate

Interventions

DRUG

177Lu-PSMA-I&T

Radioligand therapy

DRUG

Abiraterone with Prednisone or Enzalutamide

Hormone Therapy

Sponsors & Collaborators

  • Curium US LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2024-08-02
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05204927 on ClinicalTrials.gov