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ACTIVE NOT RECRUITING Phase 3

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

NCT05204927 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 439 participants
Start Date 2022-02-14
Est. Completion 2029-02
Phase Phase 3

Sponsor

Curium US

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05204927

The ClinicalTrials.gov registry entry for NCT05204927 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 439 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Curium US, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05204927 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05204927?

The interventions under investigation include: 177Lu-PSMA-I&T (DRUG), Abiraterone with Prednisone or Enzalutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05204927?

This trial is sponsored by Curium US, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial