RecruitingPhase 2NCT06474806

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

An Open-label, Two-part, Phase 2 Clinical Trial to Investigate the Safety and Diagnostic Performance of uPAR PET Imaging for Non-invasive Classification of ISUP Grades Among Patients With Localised, Untreated Prostate Cancer.


Sponsor

Curasight

Enrollment

168 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of PET scan using a tracer called uPAR (a protein found more often on cancer cells) to evaluate localized prostate cancer — cancer that has not spread beyond the prostate. The goal is to see if this imaging tool can safely and accurately help doctors assess the extent of prostate cancer compared to existing methods. **You may be eligible if...** - You have been diagnosed with prostate cancer confirmed by tissue biopsy - Your cancer is classified as ISUP grade 1, 2, or 3 (a measure of how aggressive the cancer looks under the microscope) - Your cancer appears localized (has not spread to lymph nodes or distant organs) - You have had a prostate biopsy within the last 1 to 6 months (at least 1 month ago to avoid inflammation affecting the scan) - You are generally in good health (ECOG performance status 0–2) **You may NOT be eligible if...** - You have previously received any treatment for prostate cancer (surgery, radiation, hormones, chemo) - You have chronic prostatitis or an active urinary/prostate infection - You have poor bone marrow, kidney, liver, heart, or lung function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG64Cu-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.


Locations(4)

Aalborg University Hospital

Aalborg, Denmark

Vejle Hospital

Vejle, Denmark

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital

Skåne, Sweden

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NCT06474806


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