Clinical trial · Interventional
Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed Cognitive Fusion TRUS Guided Prostate Biopsy (PROBIOP)
Comparison of Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided (Cognitive Fusion) Prostate Biopsy in PIRADS 4 and 5 Lesions: A Pilot Study to Assess Diagnostic Performance and Patient Safety
NCT05137561CI-TRIAL-00093237PROBIOPcompletedPhase 2 / Phase 3ClinicalTrials.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)
The present study aimed to compare the diagnostic accuracy, radiation exposure, complication rates between 68Ga-PSMA PET/CT guided robotic arm assisted prostate biopsy and MRI directed TRUS guided prostate biopsy in PIRADS 4/5 lesions.
Conditions
Conditions (2)
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 |
| Prostate Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI directed TRUS guided prostate biopsy | Procedure | — | UNRESOLVED |
| PSMA PET guided prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PSMA PET/CT guided biopsy arm
- description
- PSMA PET/CT guided biopsy will be done from PSMA avid lesion of the prostate after reviewing the whole body PSMA PET/CT scan.
- interventionNames
- Procedure: PSMA PET guided prostate biopsy
- type
- ACTIVE_COMPARATOR
- label
- MRI directed TRUS guided biopsy
- description
- The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion.
- interventionNames
- Procedure: MRI directed TRUS guided prostate biopsy
Primary outcomes (2)
- measure
- Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. PIRADS 4 and 5 prostate lesions and PIRADS \</= 3 prostate lesions with high clinical suspicion. 2. Patients who are included in the study will be randomly allocated into either PSMA PET/CT guided biopsy or TRUS guided biopsy using simple randomization in RRApp Exclusion Criteria: 1. Patients with acute prostatitis/ urine culture positive. 2. Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2, and Platelet counts ≤ 80,000/mm3 3. Patients who refuse to provide the written informed consent 4. Non-cooperative patients
References
Publications (0)
Data not yet available
No reference posted for this study.