Clinical trial · Interventional
FUS-TB VS COG-TB in Small Lesions of Prostate Cancer
FUS-TB VS COG-TB in Prostate Cancer With PI-RADS 4 Small Lesions - a Predictive, Multi-center, Exploring Study
NCT06504017CI-TRIAL-00078841unknownN/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)
To compare the positive detection rates of COG-TB vs FUS-TB for prostate cancer with PI-RADS 4 small lesions.
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 |
|---|---|---|---|
| COG-TB: Cognitive Fusion guided prostate targeted Biopsy | Procedure | — | UNRESOLVED |
| FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- COG-TB: Cognitive Fusion guided prostate targeted Biopsy
- description
- Targeted Biopsy 4 cores under cognitive fusion ultrasound
- interventionNames
- Procedure: COG-TB: Cognitive Fusion guided prostate targeted Biopsy
- type
- EXPERIMENTAL
- label
- FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy
- description
- Targeted Biopsy 4 cores under MRI-TRUS Fusion ultrasound
- interventionNames
- Procedure: FUS-TB: MRI-TRUS Fusion guided prostate targeted Biopsy
Primary outcomes (1)
- measure
- detection rate of any PCa
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) male who are between 18 to 80 years old; 2) meet any of the following criteria: 1. suspicious nodules of prostate under digital rectal examination(DRE), with any PSA value; 2. PSA≥10μg/L; 3. 4μg/L≤PSA\<10μg/L,f/t PSA≤0.16; 3) suspicious lesions under mpMRI, at least one lesion \<5mm, PI-RADS 4; 4) good compliance; 5) must sign the informed consent form. Exclusion Criteria: * 1\) diagnosed prostate cancer or acute prostatitis; 2) acute infection, or clinically significant urinary tract infection; 3) performed prostate puncture within 1 month; 4) cardiac insufficiency; 5) having high risk of bleeding or taking anticoagulants for a long time; 6) severe internal or external hemorrhoids, perianal or rectal lesions; 7) having severe osteoarticular diseases that can not be performed lithotomy; 8) hypertensive crisis; 9) patients who should not be anesthetized; 10) patients with mental illness or mental disorders and unable to understand the informed consent; 11) patients with electronic devices such as built-in artificial pacemaker, cochlear implants or nerve stimulators; 12) other surgical contraindications, or those considered unsuitable by the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.