Using repeated MRI scans to decide who needs a prostate biopsy
Tests whether changes between 2 MRI scans can guide prostate biopsy decisions.
Plain-language title generated from the registry record
Registry title: Prostate Cancer Early Detection Using Serial MRI Examinations
Key facts
- Where
- Grenoble, FranceSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with a suspicious spot on a first prostate MRI who have never had a prostate biopsy. It tests deciding on a biopsy from how the spot changes between two MRI scans.
- Age
- Over 18 years
- Sex
- Men only
- Disease stage
- A PIRADS 3-5 lesion on the first prostate MRI, with no sign of spread outside the prostate capsule, to the seminal vesicles or to lymph nodes (MRI stage T2). A PIRADS 3 lesion needs a PSA density of 0.15 ng/ml/ml or more.
- Earlier treatment
- No earlier prostate biopsy. No 5-alpha reductase inhibitors or hormone therapy.
- Biomarker or test result
- PSA level of 20 ng/ml or lower. Life expectancy of more than 10 years. MRI of good enough quality (PI-QUAL score 2-3).
Main reasons for not taking part
- Known mutation in DNA repair genes or a suggestive family history
- Already under surveillance for a known MRI lesion (unless the earlier MRI was under 6 months ago)
- Severe kidney problems (GFR below 30 ml/min/1.73 m²)
- Cannot have gadolinium injection or a prostate biopsy
- MRI showing only a PIRADS 1-2 lesion
Read by machine on 12 November 2026.
Where in France
- university Hospital GrenobleGrenoble, FranceContact: Assilah bouzitNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Grenoble
- Trial code
- NCT07355504
- Record updated
- 21 January 2026
- Original description
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.Read full original descriptionShow less
Prostate Cancer Early Detection Using Serial MRI Examinations
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.
Inclusion: 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: Men already under surveillance for a known MRI lesion (except if the previous MRI was performed less than 6 months ago); 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); 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; Contraindication to gadolinium injection; Contraindication to prostate biopsy; Vulnerable persons (covered by Articles L1111-6 to L1111-8 of the French Public Health Code).