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.
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.
• Pathology-verified prostate adenocarcinoma
• International Society of Urological Pathology (ISUP) grade 1 to 3
• Localised prostate cancer (N0 and M0 status) (only required for ISUP 3 patients)
‣ Newly diagnosed patients: Staging must be performed within 6 months from enrolment into the trial.
⁃ Active surveillance: N0/M0 at the time of diagnosis and no clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Prostate biopsy within 1 to 6 months (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the PET scan)
‣ The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS.
⁃ At least 1 core must be MRI-guided.