Ireland
--:--IST
Starting soon Not applicable

Prostate Cancer Early Detection Using Serial MRI Examinations

NCT07355504 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-01-12
Last updated
2026-01-21

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

MRI Examination

MRI Examination: Patients randomized to the experimental arm will proceed with MRI surveillance. A follow-up visit is planned at 6 months with the result of a PSA test, and it is possible at each investigator's discretion, to prescribe the follow-up MRI at 6 months in case of rising PSA. Otherwise, the repeat MRI will be scheduled one year after the initial MRI. Images will also be sent to the coordinating center for central reviewing of the new MRI exam and assessment of progression.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 * Vulnerable persons (covered by Articles L1111-6 to L1111-8 of the French Public Health Code)

Primary outcome measure(s)

  • To evaluate the impact of a novel early detection strategy based on serial MRI — at 2 years
    To evaluate the impact of a novel early detection strategy based on serial MRI exams, compared to the standard of care, on the rate of definitive treatment for localized prostate cancer

Trial sites (1)

FacilityCityRegionStatus
university Hospital Grenoble Grenoble Grenoble
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07355504 on ClinicalTrials.gov ↗ ← All trials in France