Clinical trial · Interventional
PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy
Application of PSMA PET/MRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial
NCT06923657CI-TRIAL-00112825recruitingN/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)
The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.
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 Screening | — | UNRESOLVED | — |
| PSMA-PET | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy | Diagnostic Test | — | UNRESOLVED |
| TRUS guided transperineal saturation biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- The control group
- description
- The control group will receive TRUS guided transperineal saturation biopsy.
- interventionNames
- Diagnostic Test: TRUS guided transperineal saturation biopsy
- type
- EXPERIMENTAL
- label
- The experimental group
- description
- The experimental group will undergo PSMA PET/MRI examination. For those with positive PSMA PET/MRI results, a PSMA PET/MRI-TRUS guided prostate targeted biopsy will be performed based on transrectal ultrasound (TRUS) guided transperineal saturation biopsy, targeting the positive lesions. For those with negative PSMA PET/MRI results, only TRUS guided transperineal saturation biopsy will be performed.
- interventionNames
- Diagnostic Test: PSMA PET/MRI-TRUS guided prostate targeted combined saturation biopsy
Primary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Serum PSA \> 4 ng/mL * At least one prior negative prostate biopsy * At least two consecutive increases in PSA and/or PHI * Negative digital rectal examination * Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3 Exclusion Criteria * Age ≤ 30 years or \> 85 years * Concurrent presence of other malignant tumors * Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy) * Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.) * Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.) * Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment) * Incomplete clinical or pathological data
References
Publications (0)
Data not yet available
No reference posted for this study.