Clinical trial · Interventional
Multi-parametric Ultrasound Versus Multi-parametric MRI for Prostate Cancer Detection
A Prospective Cohort Study Comparing Multi-parametric Ultrasound Versus Multi-parametric MRI for Clinically Significant Prostate Cancer Detection
- 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 of this cohort study is to investigate multiparametric ultrasound versus multiparametric MRI for clinically significant prostate cancer detection in patients scheduled for initial biopsy. The main questions it aims to answer are: * whether the clinically significant prostate cancer detection rate of multiparametric ultrasound is comparable to multiparametric MRI * the any cancer detection of multiparametric ultrasound versus multiparametric MRI Participants will undergo multiparametric ultrasound and multiparametric MRI before prostate biopsy. In case of suspicious findings on ultrasound or MRI, they will undergo combined systematic biopsy and targeted biopsy. In case of nonsuspicious imaging finding, they will undergo systematic biopsy alone.
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 Biopsy | — | UNRESOLVED | — |
| PROSTATE CANCER | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate biopsy | Procedure | — | UNRESOLVED |
| Prostate imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging (multiparametric ultrasound and multiparametric MRI)
- description
- All patients will undergo multiparametric ultrasound and multiparametric MRI. In case of suspicious multiparametric ultrasound and/or multiparametric MRI,they will undergo combined targeted biopsy and systematic biopsy. In case of nonsuspicious imaging findings, only systematic biopsy will be performed.
- interventionNames
- Diagnostic Test: Prostate imaging
- Procedure: Prostate biopsy
Primary outcomes (1)
- measure
- clinically significant prostate cancer detection
- timeFrame
- Up to 12 weeks following imaging
- description
- The primary definition was Grade Group(GG) ≥ 2. The secondary definition included PROMIS definition 1 (GG ≥ 3 and/or maximal cancer core length ≥ 6 mm) and PROMIS definition 2 (GG ≥ 2 and/or maximal cancer core length ≥ 4 mm). The measurement will be based on the final prostate biopsy histopathology report.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. Scheduled for prostate biopsy; 2. Signed the informed consent. Exclusion Criteria: 1. Contraindications to MRI, such as metal implants, claustrophobia, etc; 2. Contraindications to ultrasound, such as acute myocardial infarction, acute cerebral infarction and rectal tumor after Miles operation; 3. Contraindications of prostate biopsy, such as abnormal routine urine test, coagulation function and electrocardiogram 4. Any medical condition or other event that may significantly reduce the chances of obtaining reliable data, achieving the purpose of the study or completing the study and follow-up; 5. The study doctor thinks it is not suitable to participate in this study.
References
Publications (0)
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