Menu
Not yet recruiting NCT07355504

Prostate Cancer Early Detection Using Serial MRI Examinations

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI Examination.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure 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.

Primary outcome measures

  • To evaluate the impact of a novel early detection strategy based on serial MRI [Time frame: at 2 years]
Secondary outcome measures (8)
  • To assess the impact of a new early-detection strategy based on repeated MRI [Time frame: at 5 years.]
  • To assess the impact of the new strategy on the number of prostate biopsies performed [Time frame: at 2 years and 5 years.]
  • To assess changes in therapeutic options with the new strategy [Time frame: at 2 years and 5 years.]
  • To assess the oncologic safety with Adverse pathological criteria (pT3, pN1, detectable PSA)of the new strategy compared with the usual strategy [Time frame: at 2 years and 5 years.]
  • To assess the oncologic outcomes (Biochemical recurrence-free survival, disease-specific survival and overall survival.of the new strategy compared with the usual strategy [Time frame: at 2 years and 5 years.]
  • To assess the impact of the new strategy on patients' anxiety levels and quality of life, evaluated at Day 0 and then annually for 5 years. [Time frame: at 5 years]
  • To evaluate the cost-effectiveness of the new early-detection strategy compared with the standard of care from a societal perspective [Time frame: at 5 years.]
  • To establish an MRI database enabling comparison of radiomic characteristics between patients who have progressed and those who have not, in order to identify new imaging features associated with disease progression. [Time frame: at 5 years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • university Hospital Grenoble — Grenoble

Identifiers

NCT: NCT07355504 · 38RC24.0296

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗