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

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат 64Cu-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.

Первичные конечные точки

• Part 1: Standard uptake value (SUV) max at 30, 60, and 120 minutes post-injection (p.i.) - robustness [Срок оценки: Day 1]
• Part 2: SUVmax at 60 minutes p.i. [Срок оценки: 60 minutes post-injection]

Вторичные конечные точки (12)

• Part 1: SUVmax in PET acquisitions at 60 minutes p.i. [Срок оценки: Day 1 and Day 8]
• Part 1: Cmax from periodic radioactive counts from whole blood [Срок оценки: Day 1]
• Part 1:Tmax from periodic radioactive counts from whole blood [Срок оценки: Day 1]
• Part 1: Area under curve (AUC) from periodic radioactive counts from whole blood [Срок оценки: Day 1]
• Part 1:Volume of distribution (Vd) from periodic radioactive counts from whole blood [Срок оценки: Day 1]
• Part 1:Clearance from periodic radioactive counts from whole blood [Срок оценки: Day 1]
• Part 1: Elimination of 64Cu-DOTA-AE105 into a pooled urine sample [Срок оценки: Day 1]
• Part 1: Inter-reader variability of SUVmax [Срок оценки: Day 1]
• Part 1:Intra-reader variability of SUVmax [Срок оценки: Day 1]
• Part 1: Inter-reader variation in tumour visibility [Срок оценки: Day 1]
• Part 1: Intra-reader variation in tumour visibility [Срок оценки: Day 1]
• Part 1: SUVmax using different acquisition durations [Срок оценки: Day 1]

Критерии участия

Критерии включения

• 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)

• Newly diagnosed patients: Staging must be performed within 6 months from enrolment into the trial.
• 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)

• The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS.
• At least 1 core must be MRI-guided.

Критерии исключения

• 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:

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Германия · 4 центра

• Zeisigwaldkliniken Bethanien Chemnitz — Chemnitz
• Universitätsklinikum, Düsseldorf — Düsseldorf
• Martini-klinik am UKE — Hamburg
• Klinikum rechts der Isar — Munich

Дания · 3 центра

• Herlev & Gentofte Hospital — Herlev
• Vejle Hospital — Vejle
• Aalborg University Hospital — Aalborg

Швеция · 2 центра

• Sahlgrenska University Hospital — Gothenburg
• Skåne University Hospital — Skåne

Идентификаторы

NCT: NCT06474806 · 64Cu-DOTA-AE105-101 · 2023-507111-35-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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