Clinical trial · Interventional
Unfavorable MRI But Favorable 68Ga-PSMA PET/MRI for Primary Prostate Cancer Detection
Diagnostic Performance of 68Ga-PSMA PET/MRI in Suspicious Biopsy-naive Prostate Cancer Patients With Favorable Lesion on PET But Unfavorable on MRI for Primary Prostate Cancer Detection: a Pilot Study
NCT04124107CI-TRIAL-00041126unknownN/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 perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.
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 |
|---|---|---|---|
| multiparametric MRI and 68Ga-PSMA PET/MRI | Device | — | UNRESOLVED |
| Prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate biopsy with 68Ga-PSMA PET/MRI
- description
- Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI
- interventionNames
- Device: multiparametric MRI and 68Ga-PSMA PET/MRI
- Procedure: Prostate biopsy
Primary outcomes (1)
- measure
- Detection rate of prostate cancer
- timeFrame
- 30 days post biopsy
- description
- Detection rate of prostate cancer
Secondary outcomes (3)
- measure
- Detection rates of clinically significant PCa and clinically insignificant prostate cancer
- timeFrame
- 30 days post biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men more than 18 years old with clinical suspicion of prostate cancer; 2. Serum prostate-specific antigen (PSA) \> 4 ng/ml within the previous 3 months; 3. PI-RADS score no more than 3 or normal mpMRI of prostate; 4. Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI; 5. no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; 6. Able to provide written informed consent. Exclusion Criteria: 1. Prior prostate biopsy or prostate surgery; 2. Prior treatment for prostate cancer; 3. Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); 4. Contraindication to prostate biopsy.
References
Publications (0)
Data not yet available
No reference posted for this study.