OncoMatch/Clinical Trials/NCT06474806

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

Is NCT06474806 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies 64Cu-DOTA-AE105 for prostate cancer.

Phase 2RecruitingCurasightNCT06474806Data as of May 2026

Treatment: 64Cu-DOTA-AE105 — 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Required: Stage LOCALISED

Grade: ISUP grade 1ISUP grade 2ISUP grade 3 (ISUP)

International Society of Urological Pathology (ISUP) grade 1 to 3; Localised prostate cancer (N0 and M0 status) (only required for ISUP 3 patients)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: surgery

Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy)

Cannot have received: external beam radiation therapy

Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy)

Cannot have received: brachytherapy

Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy)

Cannot have received: hormone therapy

Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy)

Cannot have received: chemotherapy

Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy)

Lab requirements

Blood counts

Participants have inadequate bone marrow function [excluded]

Kidney function

Participants have inadequate kidney function [excluded]

Liver function

Participants have inadequate liver function [excluded]

Cardiac function

Participants have inadequate heart function [excluded]

Participants have inadequate bone marrow, kidney, liver, heart, or lung function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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