Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer
- Registration Number
- NCT06474806
- Lead Sponsor
- Curasight
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 168
-
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.
- 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:
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100 MBq 64Cu-DOTA-AE105 64Cu-DOTA-AE105 For Part 1 of the trial, 9 patients will receive 100 MBq 64Cu-DOTA-AE105 Day 1 and Day 8 200 MBq 64Cu-DOTA-AE105 64Cu-DOTA-AE105 For Part 1 of the trial, 9 patients will receive 200 MBq 64Cu-DOTA-AE105 Day 1 and Day 8. For Part 2 of the trial, additional 141 patients will receive 200 Mbq 64Cu-DOTA-AE105 150 MBq 64Cu-DOTA-AE105 64Cu-DOTA-AE105 For Part 1 of the trial, 9 patients will receive 150 MBq 64Cu-DOTA-AE105 Day 1 and Day 8
- Primary Outcome Measures
Name Time Method Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness Day 1 Part 1: mean of 3 independent readings of SUVmax at positron emission tomography (PET) aquisition times 30, 60, and 120 minutes p.1
Part 2: SUVmax at 60 minutes p.i. 60 minutes post-injection Part 2: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes p.i.
- Secondary Outcome Measures
Name Time Method Part 2: SUVmax variation between local and central readers 60 minutes post-injection Part 2: mean of 3 central readers and read of 1 local reader of SUVmax in PET acquisitions at 60 minutes p.i.
Part 2: Tumour visibility in PET acquisitions 60 minutes post injection 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.
Part 2: Inter-reader variability of SUVmax 60 minutes post injection Part 2: Variability of 3 independent SUVmax readings at 60 minutes p.i.
Part 2: Inter-reader tumour visibility in PET acquisitions 60 minutes post injection 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.
Part 1:Volume of distribution (Vd) from periodic radioactive counts from whole blood Day 1 Part 1: Vd from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples
Part 1:Tmax from periodic radioactive counts from whole blood Day 1 Part 1: Tmax from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples
Part 1: Area under curve (AUC) from periodic radioactive counts from whole blood Day 1 AUC from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples
Part 1: Inter-reader variation in tumour visibility Day 1 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.
Part 1: SUVmax in PET acquisitions at 60 minutes p.i. Day 1 and Day 8 Part 1: mean of 3 independent readings of SUVmax at PET aquisition time 60 minutes Day 1 and Day 8
Part 1: Cmax from periodic radioactive counts from whole blood Day 1 Cmax from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples
Part 1:Clearance from periodic radioactive counts from whole blood Day 1 Part 1: Clearance from periodic radioactive counts from whole blood based on pre-injection and 5 post-injection samples
Part 1: Elimination of 64Cu-DOTA-AE105 into a pooled urine sample Day 1 Part 1: Activity (MBq) per mL in urine samples pooled for the 3 hours following injection
Part 1: Inter-reader variability of SUVmax Day 1 Part 1: Variability of 3 independent SUVmax readings at 30, 60, and 120-minutes p.i.
Part 1:Intra-reader variability of SUVmax Day 1 Part 1: Variability of SUVmax readings at 30, 60, and 120-minutes p.i.
Part 1: Intra-reader variation in tumour visibility Day 1 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.
Part 1: SUVmax using different acquisition durations Day 1 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
Part 1: Variation in tumour visibility using different acquisition durations in the 200 MBq cohort Day 1 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
Part 2: Intra-reader variability of SUVmax 60 minutes post injection Part 2: Variability of SUVmax readings at 60-minutes p.i.
Part 2: Intra-reader tumour visibility in PET acquisitions 60 minutes post injection 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.
Trial Locations
- Locations (4)
Vejle Hospital
🇩🇰Vejle, Denmark
Sahlgrenska University Hospital
🇸🇪Goteborg, Sweden
Skåne University Hospital
🇸🇪Skåne, Sweden
Aalborg University Hospital
🇩🇰Aalborg, Denmark