Prostate Cancer Early Detection Using Serial MRI Examinations

NCT07355504 | Not Yet Recruiting

• 1 other identifier: 38RC24.0296
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

MRI lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• To assess the impact of a new early-detection strategy based on repeated MRI

  at 5 years.

• To assess the impact of the new strategy on the number of prostate biopsies performed

  at 2 years and 5 years.

• To assess changes in therapeutic options with the new strategy

  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

  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

  at 2 years and 5 years.

Study Arms (2)

Prostate biopsy

NO INTERVENTION

Patients randomized to the standard of care arm will undergo prostate biopsies

MRI surveillance

EXPERIMENTAL

Patients randomized to the experimental arm will proceed with MRI surveillance.

Procedure: MRI Examination

Interventions

MRI Examination PROCEDURE

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.

MRI surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

university Hospital Grenoble

Grenoble, Grenoble, 38043, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Gaelle GF FIARD, Professor

CONTACT

0476767971; gfiard@chu-grenoble.fr

Assilah AB bouzit

CONTACT

0476767971; abouzit@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, controlled trial

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 21, 2026
• Study Start: January 12, 2026
• Primary Completion: January 24, 2026
• Study Completion (Estimated): January 23, 2033
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)