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

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

NCT ID: NCT06474806

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 64Cu-DOTA-AE105
Description: 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.
Arm group label: 100 MBq 64Cu-DOTA-AE105
Arm group label: 150 MBq 64Cu-DOTA-AE105
Arm group label: 200 MBq 64Cu-DOTA-AE105

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.

Criteria for 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:

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Aalborg University Hospital

Address:
City: Aalborg
Country: Denmark

Status: Recruiting

Contact:
Last name: Prof. Zacho, MD,
Email: hzacho@dcm.aau.dk

Start date: June 1, 2024

Completion date: September 1, 2025

Lead sponsor:
Agency: Curasight
Agency class: Industry

Collaborator:
Agency: ABX CRO
Agency class: Other

Source: Curasight

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06474806