Last reviewed · How we verify
A Prospective Cohort Study Comparing Multi-parametric Ultrasound Versus Multi-parametric MRI for Clinically Significant Prostate Cancer Detection (TRUSVSMPMRI)
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.
Details
| Lead sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 500 |
| Start date | 2023-12 |
| Completion | 2025-12-31 |
Conditions
- PROSTATE CANCER
- Prostate Biopsy
Interventions
- Prostate imaging
- Prostate biopsy
Primary outcomes
- clinically significant prostate cancer detection — Up to 12 weeks following imaging
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 that will be based on biopsy histopathology.
Countries
China