Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer
NCT Number: NCT06474806
Acronym: uTRACE-101
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Prostate Cancer
Interventions: DRUG: 64Cu-DOTA-AE105
Sponsor: Curasight
Collaborators: ABX CRO
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-01
Completion Date: 2025-09-01
Locations: Aalborg University Hospital, Aalborg, Denmark

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.

Primary Outcome Measures: Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness, Part 1: mean of 3 independent readings of SUVmax at positron emission tomography (PET) aquisition times 30, 60, and 120 minutes p.1, Day 1|Part 2: SUVmax at 60 minutes p.i., Part 2: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes p.i., 60 minutes post-injection
Secondary Outcome Measures: Part 1: SUVmax in PET acquisitions at 60 minutes p.i., Part 1: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes Day 1 and Day 8, Day 1 and Day 8|Part 1: Cmax from periodic radioactive counts from whole blood, Cmax from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples, Day 1|Part 1:Tmax from periodic radioactive counts from whole blood, Part 1: Tmax from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples, Day 1|Part 1: Area under curve (AUC) from periodic radioactive counts from whole blood, AUC from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples, Day 1|Part 1:Volume of distribution (Vd) from periodic radioactive counts from whole blood, Part 1: Vd from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples, Day 1|Part 1:Clearance from periodic radioactive counts from whole blood, Part 1: Clearance from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples, Day 1|Part 1: Elimination of 64Cu-DOTA-AE105 into a pooled urine sample, Part 1: Activity (MBq) per mL in urine samples pooled for the 3 hours following injection, Day 1|Part 1: Inter-reader variability of SUVmax, Part 1: Variability of 3 independent SUVmax readings at 30, 60, and 120-minutes p.i., Day 1|Part 1:Intra-reader variability of SUVmax, Part 1: Variability of SUVmax readings at 30, 60, and 120-minutes p.i., Day 1|Part 1: Inter-reader variation in tumour visibility, Part 1: Tumor visibility in PET acquisitions evaluated by individual readings (numerical rating scale \[NRS\], 0-2 rating) at 30, 60, and 120 min p.i., Day 1|Part 1: Intra-reader variation in tumour visibility, Part 1: Tumor visibility in PET acquisitions evaluated by individual readings (numerical rating scale \[NRS\], 0-2 rating) at 30, 60, and 120 min p.i., Day 1|Part 1: SUVmax using different acquisition durations, Part 1: mean of 3 independent readings of SUVmax centered around 60 minutes p.i. in frame durations of 3-, 5-, 10-, 20-, 30-, and 40-minutes, Day 1|Part 1: Variation in tumour visibility using different acquisition durations in the 200 MBq cohort, Part 1: median of 3 central readings of tumor visibility (NRS, 0-2 rating), centered around 60 minutes p.i. in frame durations of 3-, 5-, 10-, 20-, 30-, and 40-minutes, Day 1|Part 2: SUVmax variation between local and central readers, Part 2: mean of 3 central readers and read of 1 local reader of SUVmax in PET acquisitions at 60 minutes p.i., 60 minutes post-injection|Part 2: Tumour visibility in PET acquisitions, Part 2: median of 3 central readings of tumor visibility (NRS, 0-2 rating) and read of 1 local reader in PET acquisitions at 60 minutes p.i., 60 minutes post injection|Part 2: Intra-reader variability of SUVmax, Part 2: Variability of SUVmax readings at 60-minutes p.i., 60 minutes post injection|Part 2: Inter-reader variability of SUVmax, Part 2: Variability of 3 independent SUVmax readings at 60 minutes p.i., 60 minutes post injection|Part 2: Inter-reader tumour visibility in PET acquisitions, Part 2: individual readings by 3 central readers and 1 local reader of tumor visibility (NRS, 0-2 rating) in PET acquisitions at 60 minutes p.i., 60 minutes post injection|Part 2: Intra-reader tumour visibility in PET acquisitions, Part 2: individual readings by 3 central readers and 1 local reader of tumor visibility (NRS, 0-2 rating) in PET acquisitions at 60 minutes p.i., 60 minutes post injection
Other Outcome Measures: Incidence of adverse events, Part 2: Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Day 3