Prostate Cancer Early Detection Using Serial MRI Examinations (PROCEDE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: MRI Examination

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaelle GF FIARD, Professor; Phone Number: +33 0476767971; Email: gfiard@chu-grenoble.fr
• Study Contact Backup: Name: Assilah AB bouzit; Phone Number: +33 0476767971; Email: abouzit@chu-grenoble.fr

Study Locations

• France
  • Grenoble
    • Grenoble, Grenoble, France, 38043
      • University Hospital Grenoble
      • Contact: Assilah bouzit; Phone Number: +33 0476767971; Email: abouzit@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Prostate biopsy; Patients randomized to the standard of care arm will undergo prostate biopsies
Experimental: MRI surveillance; Patients randomized to the experimental arm will proceed with MRI surveillance.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the impact of a novel early detection strategy based on serial MRI	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	at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the impact of a new early-detection strategy based on repeated MRI	Time to the first event among (i) definitive treatment for localized prostate cancer, defined as one of the following procedures: radical prostatectomy, radiotherapy, brachytherapy, focal therapy; (ii) occurrence of prostate cancer metastases; (iii) all-cause death, occurring between randomization and 5-year follow-up.	at 5 years.
To assess the impact of the new strategy on the number of prostate biopsies performed	Number of biopsy procedures performed.	at 2 years and 5 years.
To assess changes in therapeutic options with the new strategy	Choice of definitive treatment, if applicable, among the following options: (i) brachytherapy, (ii) focal therapy, and (iii) unimodal therapy.	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	Adverse pathological criteria (pT3, pN1, detectable PSA) in patients treated with radical prostatectomy.	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	Biochemical recurrence-free survival, disease-specific survival (i.e., censoring non-disease-related deaths), and overall survival.	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.	HADS scale, MAX-PC questionnaire, EPIC-26 questionnaire, EQ-5D-5L questionnaire. The combination of these questionnaires will allow us to assess the level of anxiety and the quality of life of patients treated with the new strategy; we have decided to use them together for a combined evaluation.	at 5 years
To evaluate the cost-effectiveness of the new early-detection strategy compared with the standard of care from a societal perspective	ICUR. The incremental cost-utility ratio (ICUR) will be calculated by dividing the mean difference in costs by the mean difference in QALYs (estimated from the EQ-5D-5L). The ratio will be expressed as cost per healthy life-year gained.	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.	Database collecting all MRI examinations in DICOM format, along with oncologic outcomes (progression/no progression).	at 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Estimated): January 12, 2026
• Primary Completion (Estimated): January 24, 2026
• Study Completion (Estimated): January 23, 2033

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: MRI lesion
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 38RC24.0296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No