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.

64Cu-DOTA-AE105-101

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.

2024-06-01

2025-09-01

2025-09-01

Recruiting

Early phase I

168

Inclusion Criteria: * 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) 1. Newly diagnosed patients: Staging must be performed within 6 months from enrolment into the trial. 2. 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) 1. The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS. 2. At least 1 core must be MRI-guided. Exclusion Criteria: * Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy) * Chronic prostatitis (any signs or symptoms of chronic bacterial prostatitis or chronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomatic inflammatory prostatitis) * Acute infections within the prostatic bed or lower urinary tract infections * Participants have inadequate bone marrow, kidney, liver, heart, or lung function:

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2024-06-26