Clinical trial · Interventional
The Diagnostic Application of PSMAPET/MR in Patients Undergoing Secondary Prostate Puncture
The Diagnostic Application of PSMA PET/MR in Patients with PSA <20 Ng/ml and Initial Negative Prostate Biopsy
NCT06901492CI-TRIAL-00087885not yet recruitingN/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 present study is designed to explore the value of targeted puncture guided by PSMA PET/CT or mpMRI in the diagnosis of patients with low PSA and initial negative prostate biopsy
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MpMRI | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| PSMA PET/CT | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate biopsy guided by mpMRI/US | Diagnostic Test | — | UNRESOLVED |
| Prostate biopsy guided by PSMA PET/CT | Diagnostic Test | — | UNRESOLVED |
| Systematic prostate biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- PET+/mpMRI+ group
- description
- Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on both PSMA PET and mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.
- interventionNames
- Diagnostic Test: Prostate biopsy guided by PSMA PET/CT
- type
- EXPERIMENTAL
- label
- PET+/mpMRI- group
- description
- Patients in this group will undergo 68Ga-PSMA PET/mpMRI imaging, and the results show positive findings on PSMA PET and negative on mpMRI. These patients will undergo prostate biopsy guided by PSMA PET/CT.
- interventionNames
- Diagnostic Test: Prostate biopsy guided by PSMA PET/CT
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥40 years, male; 2. Serum PSA level 4-20 ng/mL; 3. Serum PSA level 4-20 ng/mL; 4. No contraindications to PSMA-PET/CT or MRI; 5. Signed informed consent. Exclusion Criteria: 1. Serum PSA \>20 ng/mL; 2. History of prostate surgery/radiotherapy; 3. Acute prostatitis; 4. Coagulation disorders or active infection; 5. Severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions; 6. Allergy to local anesthetics; 7. Inability to tolerate the biopsy procedure.
References
Publications (0)
Data not yet available
No reference posted for this study.