Prostate CancerPROCEDENCT07355504
Prostate Cancer Early Detection Using Serial MRI Examinations
A study testing MRI Examination in people with Prostate Cancer, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI Examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2026to 23 Jan 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
university Hospital Grenoble
Grenoble, Grenoble, 38043
Assilah bouzit, 0476767971 ext. +33, abouzit@chu-grenoble.fr
About this study
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
- Being tested
- MRI Examination
- Keywords
- MRI lesion
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ExaminationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: MRI Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 2 years
Secondary outcomes (8)
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.
Measured: at 5 years.
To assess the impact of the new strategy on the number of prostate biopsies performed
Number of biopsy procedures performed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start12 Jan 2026 (estimated)
- Primary completion24 Jan 2026 (estimated)
- Study completion23 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, controlled trial
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355504
- Sponsor's protocol ID
- 38RC24.0296
- Acronym
- PROCEDE
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Early Detection Using Serial MRI Examinations
- ClinicalTrials.gov ID
- NCT07355504
- Acronym / sponsor ID
- PROCEDE / 38RC24.0296
- Conditions
- Prostate Cancer
- Keywords
- MRI lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 Jan 2026 (estimated)
- Primary completion
- 24 Jan 2026 (estimated)
- Study completion
- 23 Jan 2033 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Prostate biopsy | No intervention | –Patients randomized to the standard of care arm will undergo prostate biopsies |
| MRI surveillance | Experimental | Procedure: MRI ExaminationPatients randomized to the experimental arm will proceed with MRI surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI ExaminationPatients 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. | Procedure or surgery | MRI surveillance |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Examination in people with Prostate Cancer, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaelle GF FIARD, Professor (0476767971 ext. +33, gfiard@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of a novel early detection strategy based on serial MRI (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.