Clinical trial · Interventional
Prostate Cancer Early Detection Using Serial MRI Examinations
NCT07355504CI-TRIAL-00101264PROCEDEnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI Examination | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Prostate biopsy
- description
- Patients randomized to the standard of care arm will undergo prostate biopsies
- type
- EXPERIMENTAL
- label
- MRI surveillance
- description
- Patients randomized to the experimental arm will proceed with MRI surveillance.
- interventionNames
- Procedure: MRI Examination
Primary outcomes (1)
- measure
- To evaluate the impact of a novel early detection strategy based on serial MRI
- timeFrame
- at 2 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.