Prostate Cancer Early Detection Using Serial MRI Examinations (PROCEDE)

January 12, 2026 updated by: University Hospital, Grenoble
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
380

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Grenoble
      • Grenoble, Grenoble, France, 38043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the impact of a novel early detection strategy based on serial MRI
Time Frame: at 2 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the impact of a new early-detection strategy based on repeated MRI
Time Frame: at 5 years.
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
Time Frame: at 2 years and 5 years.
Number of biopsy procedures performed.
at 2 years and 5 years.
To assess changes in therapeutic options with the new strategy
Time Frame: at 2 years and 5 years.
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
Time Frame: at 2 years and 5 years.
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
Time Frame: at 2 years and 5 years.
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.
Time Frame: at 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
Time Frame: at 5 years.
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.
Time Frame: at 5 years
Database collecting all MRI examinations in DICOM format, along with oncologic outcomes (progression/no progression).
at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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