Prostate Cancer Early Detection Using Serial MRI Examinations (PROCEDE)

Grenoble Alpes University Hospital Center (CHU)

Status

Not yet enrolling

Conditions

Prostate Cancer

Treatments

Procedure: MRI Examination

Study type

Interventional

Funder types

Other

Identifiers

NCT07355504

38RC24.0296

Details and patient eligibility

About

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.

Enrollment

380 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)