Clinical trial · Interventional
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
- 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 paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that additional MRI-targeted biopsy will detect more clinically significant cancers than standard TRUS biopsy. Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of clinically significant prostate cancer.
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 |
|---|---|---|---|
| Artemia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI tartget biopsy
- description
- 1. MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist. 2. Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.
- interventionNames
- Device: Artemia
Primary outcomes (1)
- measure
- Proportion of clinically significant prostate cancer (≥Gleason score 3+4)
- timeFrame
- 2 week after the procedure
Secondary outcomes (8)
- measure
- Proportion of clinically insignificant prostate cancer (Gleason score 6)
- timeFrame
- 2 week after the procedure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Men undergoing a first-time prostate biopsy to rule out cancer * 2\. Serum PSA ≥3ng/mL, ≤20ng/mL * 3\. Age≥50 years, ≤80 years * 4\. Clinical stage ≤T2c * 5\. Patients must be able to provide written informed consent. Exclusion Criteria: * 1\. Patients has any prior needle biopsy of the prostate * 2\. Patients has a prior history of prostate cancer * 3\. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy * 4\. Patients has a prior history of BPH operation * 5\. Patient with uncorrectable coagulopathies * 6\. Unable to tolerate a TRUS guided biopsy. * 7\. Patients had 5-alpha reductase inhibitor in the past six months. * 8\. The patient has had a urinary tract infection or acute prostatitis in the last three months. * 9\. Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR ≤50mls/min)
References
Publications (0)
Data not yet available