Clinical trial · Interventional
A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia
Evaluation of Feasibility, Complications And Functional Results Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia: A Prospective Study
NCT04376008CI-TRIAL-00061632completedN/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 trial aims to prospectively assess the feasibility, complications and functional results of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large group of patients.
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 prostate biopsy | Procedure | — | UNRESOLVED |
| Targeted and standard prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PI-RADS 1-2
- description
- Standard prostate biopsy
- interventionNames
- Procedure: Standard prostate biopsy
- type
- EXPERIMENTAL
- label
- PI-RADS 3-5
- description
- Targeted and standard prostate biopsy
- interventionNames
- Procedure: Targeted and standard prostate biopsy
Primary outcomes (3)
- measure
- Biopsy unfinished rates
- timeFrame
- 1 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Men more than 18 years old with clinical suspicion of prostate cancer; * Serum PSA ≤ 20 ng/ml within the previous 3 months; * Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months; * No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; * Able to provide written informed consent. Exclusion Criteria: * Prior prostate biopsy or prostate surgery; * Prior treatment for prostate cancer; * Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); * Contraindication to prostate biopsy.
References
Publications (0)
Data not yet available
No reference posted for this study.