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Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer

NCT06474806 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-11-20

No results posted yet for this study

Summary

The goal of this clinical trial is to test if the experimental agent accurately determines the aggressiveness of prostate cancer (biopsy-verified ISUP grade). The aim is that the diagnostic PET imaging agent may be used as an alternative or supplement to biopsies in the monitoring of patients with low-risk prostate cancer in active surveillance.

Patients diagnosed with untreated, low-grade, localized prostate cancer may participate in the trial. The experimental diagnostic agent 64Cu-DOTA-AE105 is a radiopharmaceutical which is injected into the veins and binds to uPAR expressing cells in the tumour which can then be visualized in a PET scanner.

The main question the trial aims to answer is: Can the test drug be used alone or as a supplement to repeated biopsies to accurately assess the aggressiveness of prostate cancer?

The trial is divided in 2 parts:

* Participants in the first part will receive 2 injections of test drug on 2 different days.

* The first day the participant will receive an injection of the test drug and then be asked to lie down in the PET/CT scanner so that images of the prostate can be taken. Before and after the injection/scanning procedure the participant will have tests done. These tests will include evaluation of health status, measurement of heart function by ECG plus blood and urine samples.
* After 8 days the procedures, including injection of test drug and scanning, will be repeated.
* Participants in the second part of the trial will only have 1 injection of the test drug and subsequent PET/CT scanning. Like in Part 1 of the trial, tests will be done before and after the injection/ scanning procedure.

Conditions

Interventions

DRUG

64Cu-DOTA-AE105

AE105 is a uPAR-specific peptide that is bound to the chelator DOTA, which in turn holds the diagnostic radionuclide copper-64 (64Cu), which can be detected upon decay by PET imaging.

Sponsors & Collaborators

  • ABX CRO

    collaborator OTHER

  • Curasight

    lead INDUSTRY

Principal Investigators

  • Andreas Kjær · Curasight

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-09-01
Completion
2025-09-01

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT06474806 on ClinicalTrials.gov