Prostate Cancer
Conditions
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.
Interventions
DRUG64Cu-DOTA-AE105
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.
Sponsors
Curasight
ABX CRO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: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: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: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: 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: 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: 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: Intra-reader variability of SUVmax | 60 minutes post injection | Part 2: Variability of SUVmax readings 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 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. |
Countries
Denmark, Germany, Sweden
Contacts
CONTACTSøren Fabricius
STUDY_DIRECTORProf. Dr. Andreas Kjær
Curasight
Outcome results
None listed