NCT06474806 Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer
| NCT ID | NCT06474806 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Curasight |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 168 participants in total. It began in 2024-06-01 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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:
Contact & Investigator
Prof. Dr. Andreas Kjær
STUDY DIRECTOR
Curasight
Frequently Asked Questions
Who can join the NCT06474806 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06474806 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06474806 currently recruiting?
Yes, NCT06474806 is actively recruiting participants. Contact the research team at info@curasight.com for enrollment information.
Where is the NCT06474806 trial being conducted?
This trial is being conducted at Herlev, Denmark, Vejle, Denmark, Aalborg, Denmark, Chemnitz, Germany and 5 additional locations.
Who is sponsoring the NCT06474806 clinical trial?
NCT06474806 is sponsored by Curasight. The principal investigator is Prof. Dr. Andreas Kjær at Curasight. The trial plans to enroll 168 participants.
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