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NCT06235099 · ClinicalTrials.gov registry record · Phase 3

Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

A Phase 3 study, sponsored by Curium US.

Completed
Registry status
Phase 3
Development phase
235
Enrollment target

NCT06235099: Completed Phase 3 study, sponsored by Curium US.

NCT06235099 is a Phase 3 study that has completed, run by Curium US. The registered enrollment target is 235 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06235099, a Phase 3 study, has completed, sponsored by Curium US.

COMPLETED
Registry status
Phase 3
Development phase
235 participants
Enrollment target

Study Summary

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

Primary Outcome

To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer between 60 minutes to 240 minutes post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scann

Interventions

  • DRUG Copper Cu 64 PSMA I&T

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2024-04-01
Est. Completion 2025-02-18
Phase Phase 3
Curium US

4 total trials

What the finished NCT06235099 record still lists

NCT06235099 is an interventional study that assigns participants to a tested intervention. The registered 235 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 (70% lower).

The record links to 0 conditions, and to 1 intervention - of which Copper Cu 64 PSMA I&T is the first listed.

NCT06235099 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06235099 about?

NCT06235099 is a clinical study titled "Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer". This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

What is the current status of trial NCT06235099?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2024-04-01. Estimated completion is 2025-02-18.

What interventions are being tested in trial NCT06235099?

The interventions under investigation include: Copper Cu 64 PSMA I&T (DRUG).

Who is sponsoring clinical trial NCT06235099?

This trial is sponsored by Curium US, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06235099's enrollment target sits among peer trials

235 1296th of 2000 higher than 704 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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Source: ClinicalTrials.gov NCT06235099, the US trial registry maintained by the National Library of Medicine. NCT06235099 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.