Table of contents
- Trial overview
- Who is being studied
- What the trials measure
- Trial phase and status
- Why these trials matter
Trial overview
The available trial of 64Cu-Dota-Ae105 is an interventional study in men with localised, untreated prostate cancer.[1] The trial is titled “Safety and diagnostic performance of uPAR PET imaging in localised, untreated prostate cancer,” which shows that the study is focused on both safety and how well the scan works for diagnosis.[1]
This study uses uPAR PET imaging, a type of scan used to look at the cancer signal inside the body.[1] The source data show three intravenous injection entries for 64Cu-Dota-Ae105, but the trial record does not provide more detail about the study schedule in the text given.[1]
Who is being studied
The target population is patients with localised prostate cancer who have not yet been treated.[1] “Localised” means the cancer is still confined to the prostate, rather than being described here as spread to other parts of the body.[1]
The trial brief summary also says the study is in patients with untreated, localised prostate cancer, and the planned enrollment is 168 participants.[1] No additional eligibility rules are provided in the source data, so the exact inclusion and exclusion criteria are not available here.[1]
What the trials measure
The main outcome is SUVmax, which is the highest signal value seen on the PET scan in a chosen area.[1] In simple terms, this helps researchers see how strong the scan signal is at different times after the injection.[1]
In Part 1, the study checks whether SUVmax measurements are robust, meaning whether they stay reliable, at 100 MBq, 150 MBq, and 200 MBq in untreated, localised prostate cancer.[1] The primary outcome for this part measures SUVmax at 30, 60, and 120 minutes after injection.[1]
In Part 2, the study looks at the discriminative properties of uPAR PET, which means whether the scan can help tell one cancer grade group from another.[1] The trial specifically aims to compare ISUP grade 1 versus 2 and ISUP grade 2 versus 3 using SUVmax at 60 minutes after injection with 200 MBq.[1]
Trial phase and status
The study is listed as Phase 1 and has the status Authorised.[1] Phase 1 usually means an early study stage, where researchers first look at basic safety and early performance in a defined patient group.[1]
The trial type is interventional, which means the researchers are actively giving the study injection and then measuring the scan results.[1] The enrollment listed in the source data is 168 participants.[1]
Why these trials matter
These trials are trying to learn whether 64Cu-Dota-Ae105 can support better imaging in early prostate cancer.[1] If the scan gives clear and reliable results, it may help researchers judge how well the imaging method separates different tumour grades.[1]
For patients, the key point is that the study is not described as a treatment trial, but as an imaging study.[1] The focus is on scan quality, measurement reliability, and diagnostic performance in untreated, localised prostate cancer.[1]
