Clinical trial · Interventional
MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy
PROMUC Trial-Comparison of Magnetic Resonance Imaging-Ultrasound Fusion and Cognitive Registration in MR-targeted Prostate Biopsy: A Randomized Controlled Trial
NCT04953351CI-TRIAL-00052572PROMUCunknownN/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)
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive registration targeted biopsy and TRUS-system biopsy | Procedure | — | UNRESOLVED |
| MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cognitive registration targeted biopsy
- interventionNames
- Procedure: Cognitive registration targeted biopsy and TRUS-system biopsy
- type
- ACTIVE_COMPARATOR
- label
- MRI-ultrasound fusion targeted biopsy
- interventionNames
- Procedure: MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy
Primary outcomes (1)
- measure
- Detection rates of clinically significant PCa in FUS-TB and COG-TB
- timeFrame
- When histology results available, at an expected average of 30 days post-biopsy
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men more than 18 years old with clinical suspicion of prostate cancer; 2. Serum PSA ≤ 20 ng/ml within the previous 3 months; 3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months; 4. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; 5. mpMRI PI-RADS V2.1 score ≥3； 6. Able to provide written informed consent. Exclusion Criteria: 1. Prior prostate biopsy or prostate surgery; 2. Prior treatment for prostate cancer; 3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); 4. Contraindication to prostate biopsy; 5. Men in whom artifact would reduce the quality of the MRI.
References
Publications (0)
Data not yet available
No reference posted for this study.