This clinical trial is focused on studying prostate cancer, specifically in patients who have been newly diagnosed with high-risk or very-high-risk forms of the disease. The study will use a special imaging technique called [18F]PSMA-1007 PET/CT. This method combines two types of scans: a PET scan, which shows how tissues and organs are functioning, and a CT scan, which provides detailed images of the inside of the body. The purpose of the study is to evaluate how well this imaging technique can detect cancer that has spread to the pelvic lymph nodes, which are small glands that help fight infection.
Participants in the study will receive an injection of a solution called Radelumin, which contains a substance that helps highlight areas of cancer during the PET/CT scan. The study will compare the results of the PET/CT scans with the findings from a biopsy, which is a procedure where a small sample of tissue is taken from the body to be examined under a microscope. This comparison will help determine the accuracy of the PET/CT scans in identifying cancer spread.
The study will be conducted over a period of time, during which participants will undergo the PET/CT scan and have their results analyzed by three independent experts who are not aware of the patients’ clinical information. This approach ensures an unbiased assessment of the imaging technique’s effectiveness. The study aims to provide valuable information that could improve the diagnosis and treatment planning for patients with high-risk prostate cancer.



France
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