Clinical trial NCT06474806: Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer
Official title: An Open-label, Two-part, Phase 2 Clinical Trial to Investigate the Safety and Diagnostic Performance of uPAR PET Imaging for Non-invasive Classification of ISUP Grades Among Patients With Localised, Untreated Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Curasight
Sponsor class: INDUSTRY
Collaborators: name: ABX CRO
First posted: 2024-06-26
Enrollment: 168
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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:

Primary outcomes:
measure: Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness
timeFrame: Day 1
measure: Part 2: SUVmax at 60 minutes p.i.
timeFrame: 60 minutes post-injection
Secondary outcomes:
measure: Part 1: SUVmax in PET acquisitions at 60 minutes p.i.
timeFrame: Day 1 and Day 8
measure: Part 1: Cmax from periodic radioactive counts from whole blood
timeFrame: Day 1
measure: Part 1:Tmax from periodic radioactive counts from whole blood
timeFrame: Day 1
measure: Part 1: Area under curve (AUC) from periodic radioactive counts from whole blood
timeFrame: Day 1
measure: Part 1:Volume of distribution (Vd) from periodic radioactive counts from whole blood
timeFrame: Day 1
measure: Part 1:Clearance from periodic radioactive counts from whole blood
timeFrame: Day 1
measure: Part 1: Elimination of 64Cu-DOTA-AE105 into a pooled urine sample
timeFrame: Day 1
measure: Part 1: Inter-reader variability of SUVmax
timeFrame: Day 1
measure: Part 1:Intra-reader variability of SUVmax
timeFrame: Day 1
measure: Part 1: Inter-reader variation in tumour visibility
timeFrame: Day 1
measure: Part 1: Intra-reader variation in tumour visibility
timeFrame: Day 1
measure: Part 1: SUVmax using different acquisition durations
timeFrame: Day 1
measure: Part 1: Variation in tumour visibility using different acquisition durations in the 200 MBq cohort
timeFrame: Day 1
measure: Part 2: SUVmax variation between local and central readers
timeFrame: 60 minutes post-injection
measure: Part 2: Tumour visibility in PET acquisitions
timeFrame: 60 minutes post injection
measure: Part 2: Intra-reader variability of SUVmax
timeFrame: 60 minutes post injection
measure: Part 2: Inter-reader variability of SUVmax
timeFrame: 60 minutes post injection
measure: Part 2: Inter-reader tumour visibility in PET acquisitions
timeFrame: 60 minutes post injection
measure: Part 2: Intra-reader tumour visibility in PET acquisitions
timeFrame: 60 minutes post injection
Other outcomes:
measure: Incidence of adverse events
timeFrame: Day 3
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Skåne
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Curasight
name: Andreas Kjær
role: STUDY_DIRECTOR
References: