Actively Recruiting
Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer
Led by Curasight · Updated on 2024-11-20
168
Participants Needed
4
Research Sites
65 weeks
Total Duration
On this page
Sponsors
C
Curasight
Lead Sponsor
A
ABX CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathology-verified prostate adenocarcinoma
- ISUP grade 1 to 3
- Localised prostate cancer (N0 and M0 status) for ISUP 3 patients
- Newly diagnosed patients must have staging within 6 months before enrollment
- Active surveillance patients must have N0/M0 status and no suspicion of cancer outside the prostate
- ECOG performance status 0 to 2
- Prostate biopsy within 1 to 6 months, with at least one MRI-guided core
You will not qualify if you...
- Any prior prostate cancer treatment (surgery, radiation, hormone therapy, chemotherapy)
- Chronic prostatitis or inflammatory prostatitis diagnosis
- Acute infections in the prostate or lower urinary tract
- Inadequate bone marrow, kidney, liver, heart, or lung function
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Aalborg University Hospital
Aalborg, Denmark
Actively Recruiting
2
Vejle Hospital
Vejle, Denmark, 7100
Actively Recruiting
3
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Actively Recruiting
4
Skåne University Hospital
Skåne, Sweden, 20502
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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