Study on the Safety and Effectiveness of 64Cu-DOTA-AE105 PET Imaging for Patients with Localized, Untreated Prostate Cancer

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What is this study about?

This clinical trial is focused on studying prostate cancer, a condition where cells in the prostate gland grow uncontrollably. The trial will use a special imaging technique called uPAR PET imaging to help classify the severity of the cancer in patients who have localized and untreated prostate cancer. The imaging involves a solution called 64Cu-DOTA-AE105, which is injected into the body to help visualize the cancer during the scan.

The purpose of the study is to investigate the safety and effectiveness of this imaging method in identifying different grades of prostate cancer. The study will be conducted in two parts. In the first part, the focus will be on understanding how well the imaging works at different doses of the injected solution. In the second part, the study will look at how accurately the imaging can distinguish between different grades of prostate cancer.

Participants in the study will receive the injection of 64Cu-DOTA-AE105 and undergo PET imaging at various times to assess the visibility of the cancer. The study aims to provide valuable information on how this imaging technique can be used to better understand and classify prostate cancer, potentially leading to improved diagnosis and treatment options in the future.

1 joining the study

Upon joining the study, the patient is confirmed to have prostate cancer that is localized and untreated. The cancer must be verified through pathology, and the patient should have undergone a prostate biopsy within 1 to 6 months prior to the first planned injection of the study medication.

2 initial injection

The patient receives an injection of 64Cu-DOTA-AE105, a solution administered intravenously. The dose may vary between 100 MBq, 150 MBq, and 200 MBq, depending on the study requirements.

3 imaging and monitoring

After the injection, the patient undergoes PET imaging to assess the uptake of the medication. Imaging is conducted at 30, 60, and 120 minutes post-injection to measure the maximum standardized uptake value (SUVmax).

The primary focus is on the SUVmax at 30, 60, and 120 minutes post-injection, with additional evaluations at 60 minutes on days 1 and 8.

4 follow-up imaging

Further PET imaging is performed to evaluate the tumor visibility and the SUVmax at 60 minutes post-injection. This helps in classifying the cancer grades according to the International Society of Urological Pathology (ISUP) standards.

5 completion of study participation

The study aims to conclude by August 29, 2025. The patient’s participation involves periodic assessments and imaging to monitor the diagnostic performance and safety of the medication.

Who Can Join the Study?

The patient must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of prostate cancer.
There must be pathology material available for a central review, meaning tissue samples from the cancer must be accessible for further examination.
The cancer must be classified as ISUP grade 1 to 3. ISUP stands for the International Society of Urological Pathology, which grades the severity of prostate cancer.
The prostate cancer must be localized, meaning it has not spread beyond the prostate. This is indicated by N0 (no regional lymph node involvement) and M0 (no distant metastasis) status. This requirement is specifically for patients with ISUP grade 3.
For newly diagnosed patients, staging tests must be done within 6 months before joining the trial.
For other patients, including those under active surveillance (AS), the cancer must have been N0/M0 at diagnosis, with no signs of cancer spreading beyond the prostate at the time of joining the trial.
The patient must have had a prostate biopsy (a procedure to remove small samples of prostate tissue) between 1 to 6 months before the first planned injection of the study drug, 64Cu-DOTA-AE105. Patients with a biopsy in the last month are not eligible to avoid possible inflammation affecting the PET scan results.
The biopsy can be part of the initial staging, a confirmatory biopsy, or a series of biopsies as part of an active surveillance or watchful waiting program.
At least one biopsy sample must be guided by MRI (Magnetic Resonance Imaging), which is a type of scan that uses magnetic fields and radio waves to create detailed images of the inside of the body.
Only male patients are eligible for this trial.

Who Cannot Join the Study?

Patients who have already received treatment for prostate cancer cannot participate.
Only male patients are eligible, so female patients cannot participate.
Patients who are considered part of a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Lunds Universitet	Lund	Sweden
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Ujfidcmdyj Muynela Ckxzwp Hfrwhnrcktpucajlc	Hamburg	Germany
Gfkqwffncu Ulgzfsdgqy Vpmlqxa Rughfnrq Ijwdoixql	Gothenburg	Sweden
Hsdefc Heepvbbt	Herlev	Denmark
Urujhdtjywnfydzmxjubd Dwntscikapf Abk	Duesseldorf	Germany

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.01.2024
Germany	Recruiting	01.01.2024
Sweden	Recruiting	01.01.2024

Trial locations

Investigated drugs:

64Cu-Dota-Ae105

uPAR PET Imaging is a diagnostic technique used in this clinical trial to help classify prostate cancer grades in patients who have not yet received treatment. It involves using a special imaging method to visualize certain proteins in the body, which can help doctors understand the severity of the cancer. This technique is being tested for its ability to accurately differentiate between different grades of prostate cancer, which can be crucial for determining the best treatment approach.

Investigated diseases:

Prostate cancer

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulties with urination, blood in the urine, or pelvic discomfort. In some cases, it may spread to other parts of the body, such as the bones or lymph nodes. The progression and symptoms can vary widely among individuals.

Trial ID:

2023-507111-35-00

Protocol code:

64Cu-DOTA-AE105-101

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of 64Cu-DOTA-AE105 PET Imaging for Patients with Localized, Untreated Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?