NCT07355504

Prostate Cancer Early Detection Using Serial MRI Examinations

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-01-24
• Completion: 2033-01-23
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: France