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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507111-35-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| ABX CRO | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 MBq 64Cu-DOTA-AE105 | Experimental | For Part 1 of the trial, 9 patients will receive 100 MBq 64Cu-DOTA-AE105 Day 1 and Day 8 |
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| 150 MBq 64Cu-DOTA-AE105 | Experimental | For Part 1 of the trial, 9 patients will receive 150 MBq 64Cu-DOTA-AE105 Day 1 and Day 8 |
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| 200 MBq 64Cu-DOTA-AE105 | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-DOTA-AE105 | Drug | AE105 is a uPAR-specific peptide that is bound to the chelator DOTA, which in turn holds the diagnostic radionuclide copper-64 (64Cu), which can be detected upon decay by PET imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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)
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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Søren Fabricius | Contact | +45 22830160 | info@curasight.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Andreas Kjær | Curasight | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev & Gentofte Hospital | Recruiting | Herlev | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The trial consist on 2 parts: Part 1 will evaluate 3 different doses of 64Cu-DOTA-AE105 in parallel (100, 150, or 200 MBq) in 27 patients (randomized 1:1:1) . Part 2 will evaluate 1 dose of 64Cu-DOTA-AE105 (200 MBq) in 141 patients
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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 |
| Vejle Hospital | Recruiting | Vejle | Denmark | 7100 | Denmark |
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| Aalborg University Hospital | Recruiting | Aalborg | Denmark |
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| Zeisigwaldkliniken Bethanien Chemnitz | Recruiting | Chemnitz | Germany |
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| Universitätsklinikum, Düsseldorf | Recruiting | Düsseldorf | Germany |
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| Martini-klinik am UKE | Recruiting | Hamburg | Germany |
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| Klinikum rechts der Isar | Recruiting | Munich | Germany |
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| Sahlgrenska University Hospital | Recruiting | Gothenburg | 41345 | Sweden |
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| Skåne University Hospital | Recruiting | Skåne | 20502 | Sweden |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |