NCT07355504Not yet recruiting
Prostate Cancer Early Detection Using Serial MRI Examinations
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 12 Jan 2026
- Primary completion date
- 24 Jan 2026
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Prostate cancer
- NCT number
- NCT07355504
What you commit to
- Study type: Interventional
- Planned participants: 380
- From 12 Jan 2026 to the primary completion date, 24 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- Patient with severe renal insufficiency (GFR \< 30 ml/min/1.73 m²)
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| university Hospital Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.