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NCT05204927 · ClinicalTrials.gov registry record · Phase 3
177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer
A Phase 3 study of Metastasis From Malignant Tumor of Prostate, sponsored by Curium US.
- Active
- Registry status
- Phase 3
- Development phase
- 439
- Enrollment target
- 20
- Study locations
NCT05204927: Active Phase 3 study of Metastasis From Malignant Tumor of Prostate, sponsored by Curium US.
NCT05204927 is a Phase 3 study of Metastasis From Malignant Tumor of Prostate that is active but no longer recruiting, run by Curium US. The registered enrollment target is 439 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05204927, a Phase 3 study of Metastasis From Malignant Tumor of Prostate, is active but no longer recruiting, sponsored by Curium US.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 439 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 177Lu-PSMA-I&T
- DRUG Abiraterone with Prednisone or Enzalutamide
Study Locations (20)
California
- Providence Medical Foundation - Fullerton
- Long Beach Memorial Center - Long Beach
- Hoag Memorial Hospital Presbyterian - Newport Beach
- San Francisco VA Health Care System - San Francisco
- University of California, San Francisco - San Francisco
- Providence Saint John's Health Center - Santa Monica
Florida
- GenesisCare USA - Boca Raton
- Biogenix Molecular LLC - Miami
- Orlando Health Cancer Institute - Orlando
- GenesisCare USA - Plantation
- Florida Urology Partners, LLP - Tampa
Michigan
- Henry Ford Hospital - Detroit
- BAMF Health I PC - Grand Rapids
- Michigan Institute of Urology - Troy
- GenesisCare USA - Troy
Illinois
- Northwestern Memorial Hospital - Chicago
- NorthShore University HealthSystem-Evanston Hospital - Evanston
Maryland
- John Hopkins Hospital - Baltimore
- Kaiser Permanente Gaithersburg Medical Center - Gaithersburg
Arizona
- Arizona Institute of Urology, PPLC - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 439 participants |
| Start Date | 2022-02-14 |
| Est. Completion | 2029-02 |
| Phase | Phase 3 |
What the registry record for NCT05204927 still lists
NCT05204927 is an interventional study that assigns participants to a tested intervention. The registered 439 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Metastasis From Malignant Tumor of Prostate appearing as the primary indexed condition, and to 2 interventions - of which 177Lu-PSMA-I&T is the first listed.
NCT05204927 names 20 study sites across 6 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT05204927 about?
NCT05204927 is a clinical study titled "177Lu-PSMA-I&T for 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.
What is the current status of trial NCT05204927?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 439 participants. The study started on 2022-02-14. Estimated completion is 2029-02.
What conditions does trial NCT05204927 study?
This clinical trial studies the following conditions: Metastasis From Malignant Tumor of Prostate.
What interventions are being tested in trial NCT05204927?
The interventions under investigation include: 177Lu-PSMA-I&T (DRUG), Abiraterone with Prednisone or Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT05204927?
This trial is sponsored by Curium US, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05204927 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05204927's enrollment target sits among peer trials
439 873rd of 2000 higher than 1,127 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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