Clinical trial · Observational
Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of csPCa in Lesions With PI-RADS Score 3
Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of Clinical Significant Prostate Cancer in Lesions With Prostate Imaging Reporting and Data System Score 3
- 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 purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study is a prospective, observational study, single-center research. After recruiting patients who are suspected prostate cancer with a mpMRI PI-RADS version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68Ga-PSMA PET/MRI will be performed. Lesions will be reaccessed based on PET/MRI findings and compared with the pathological results.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- detection rate
- timeFrame
- one year
- description
- detection rate of csPCa
Secondary outcomes (1)
- measure
- detection rate
- timeFrame
- one year
- description
- detection rate of non-csPCa
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * males over 18 years old suspected for prostate cancer * serum PSA between 4ng/ml and 20ng/ml in recent two months * mpMRI PI-RADS version2 scores 3 in recent two months * willing to undertake prostate biopsy * no evidence of non-cancerous factors interfere PSA level, such as catheter insertion, bladder stones, urinary tract infections or drug (e.g. finasteride) * ECOG 0-1 Exclusion Criteria: * history of prostate biopsy or other operations * history of prostate cancer associated treatment * contraindications for MRI or PET examination (e.g. claustrophobia, pacemakers, hip metal implants, hyperglycemia, glomerular filtration rate less than 50 ml/min) * not suitable for prostate biopsy (e.g. coagulation dysfunction, skin infection at perineal puncture site)
References
Publications (0)
Data not yet available