Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer

Phase 2RecruitingNCT06474806

Curasight168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

168

Conditions

Interventions

64Cu-DOTA-AE105DRUG

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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:

Locations (9)

Herlev & Gentofte Hospital

Herlev, Copenhagen, Denmark

RECRUITING

Vejle Hospital

Vejle, Denmark, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Zeisigwaldkliniken Bethanien Chemnitz

Chemnitz, Germany

RECRUITING

Universitätsklinikum, Düsseldorf

Düsseldorf, Germany

RECRUITING

Martini-klinik am UKE

Hamburg, Germany

RECRUITING

Klinikum rechts der Isar

Munich, Germany

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Skåne University Hospital

Skåne, Sweden

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 60 minutes post-injection

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Day 1

Part 1:Intra-reader variability of SUVmax

Part 1: Variability of SUVmax readings at 30, 60, and 120-minutes p.i.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.