Prostate Cancer Early Detection Using Serial MRI Examinations

Starting soon · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07355504

Run by

University Hospital, Grenoble

People needed

380

Starts

2026-01-12

Expected to finish

2033-01-23

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Vulnerable persons (covered by Articles L1111-6 to L1111-8 of the French Public Health Code)

Where it is running

• university Hospital Grenoble — Grenoble, Grenoble, France

Full record on ClinicalTrials.gov

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