Prostate Cancer Early Detection Using Serial MRI Examinations (NCT07355504) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prostate Cancer Early Detection Using Serial MRI Examinations
France380 participantsStarted 2026-01-12
Plain-language summary
The rationale of the PROCEDE trial is to explore a novel early detection strategy in which biopsy decision does not rely on one single MRI examination, but on the progression of the MRI lesion between 2 consecutive exams, with the objective of reducing the number of unnecessary biopsies, detection of non-clinically prostate cancer and, ultimately, overtreatment.
Who can participate
Age range
18 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:
* Men aged over 18 years
* Men with an estimated life expectancy of more than 10 years
* Biopsy-naïve men
* PSA level ≤ 20 ng/ml
* Presence, on the first multiparametric prostate MRI, of a PIRADS 3-5 lesion confirmed by local rereading if the MRI was performed outside the center
* MRI of sufficient quality (PI-QUAL score 2-3)
* PIRADS 3 lesion with a PSA density \<0.15 ng/ml/ml
* No signs of extracapsular extension or seminal vesicle invasion (MRI stage T2 confirmed by local rereading if MRI performed outside the center)
* No suspicious lymph node (confirmed by local rereading if MRI performed outside the center)
* Patient is insured (affiliated with the national health insurance system or benefiting from such coverage)
* Signed informed consent form
Exclusion Criteria:
* Men already under surveillance for a known MRI lesion (except if the previous MRI was performed less than 6 months ago)
* Known mutation in DNA repair genes or suggestive family history
* PIRADS 3 lesion with PSA density \< 0.15 ng/ml/ml
* PIRADS 5 lesion with suspected extracapsular extension or seminal vesicle invasion
* Suspicion of lymph node involvement
* Multiparametric prostate MRI showing a PIRADS 1-2 lesion
* Use of treatments that may modify the appearance of MRI lesions: 5-alpha reductase inhibitors, hormone therapy
* Patient with severe renal insufficiency (GFR \< 30 ml/min/1.73 m²)
* Contraindication to gadolinium injection
* Contraindication to prostate biopsy
* Vulnerabl…
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.
What they're measuring
1
To evaluate the impact of a novel early detection strategy based on serial MRI