Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated … (NCT07766122) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated With HIFU
France30 participantsStarted 2026-10
Plain-language summary
There would appear to be a strong interest in functional nuclear imaging for assessing the response to focal PaC treatment. Investigator team hypothesise that the diagnostic performance of PSMA PET is noninferior to that of MRI in detecting clinically significant recurrent PaC after treatment with HIFU. The main objective was to evaluate the diagnostic performance of PSMA PET compared with MRI with reference to the gold standard of prostate biopsy one year after HIFU.
Who can participate
Age range
70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with prostate cancer
* Age ≥ 70 years (HAS 2023)
* Life expectancy \> 5 years
* Clinical stage Clinical stage T1c - T2a PSA \< 20 ng/ml Biopsy :ISUP 2 unilateral on a maximum of 2 contiguous sextants with or without ipsilateral or contralateral focus ISUP1 single focus or multiple foci if only one ISUP 2 focus on targeted biopsy
* Imaging Single lesion PIRADS 3 or 4 or 5 Volume of prostate gland \< 150 ml
* Enrolled in a social security scheme
* Signature of consent
Exclusion Criteria:
* Evidence of extra-prostatic extension or invasion of the seminal vesicles.
* Any condition that, in the judgement of the investigators, would interfere with the subject's ability to
* provide informed consent, comply with study instructions, expose the subject to increased risk, or interfere with the interpretation of study results.
* Patients deprived of their liberty or under legal protection (curatorship and guardianship, safeguard of justice)
* Hypersensitivity to the active substances or to any of the excipients
* Conditions contraindicating magnetic resonance imaging (MRI), such as the presence of internal metallic devices.
* Chronic kidney disease with an eGFR ≤ 60 mL/min
* Liver failure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.