NCT06474806RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 6 Jun 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- Curasight
- Diseases
- Prostate cancer
- NCT number
- NCT06474806
- EU CT number
- 2023-507111-35-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 168
- From 1 Jun 2024 to the primary completion date, 30 Jan 2027
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy)
Other illness
- 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:
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
| Gothenburg University Vaccine Research Institute Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Lunds Universitet Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.