Clinical trial · Interventional
Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection
Diagnostic Efficiency With Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Transperineal Ultrasound-guided Biopsy in Biopsy-naïve Suspicious Prostate Cancer Patients: A Randomized Controlled Trial
NCT03572946CI-TRIAL-00041123unknownN/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 mpMRI-targeted biopsy compared to transperineal standard 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 Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard biopsy | Procedure | — | UNRESOLVED |
| Targeted prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- target biopsy group
- description
- Targeted prostate biopsy
- interventionNames
- Procedure: Targeted prostate biopsy
- type
- ACTIVE_COMPARATOR
- label
- standard biopsy group
- description
- Standard prostate biopsy
- interventionNames
- Procedure: Standard biopsy
Primary outcomes (1)
- measure
- Detection rates of clinically significant PCa
- timeFrame
- 30 days post biopsy
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 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 score 4 or 5； 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.
References
Publications (0)
Data not yet available
No reference posted for this study.