Multi-parametric Ultrasound Versus Multi-parametric MRI for Prostate Cancer Detection

Not Applicable

Not yet recruiting

• Conditions: PROSTATE CANCER; Prostate Biopsy
• Interventions: Diagnostic Test: Prostate imaging; Procedure: Prostate biopsy

• Registration Number: NCT06183905
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

In recent years, the multi-parametric MRI targeted biopsy showed inspiring results for improving clinically significant prostate cancer (PCa) detection rate \[1\]. Two techniques have been developed for MRI targeted prostate biopsy: in-bore MRI guided biopsy and MRI/ultrasound fusion biopsy. However, these biopsy techniques require specific equipment and software. Moreover, MRI has contradictions and cannot be performed in all patients. Therefore, an imaging targeted biopsy adjunct to MRI targeted biopsy is needed.

Besides MRI, multi-parametric ultrasound can also visualize PCa lesions by providing information about the blood supply, perfusion and stiffness of the prostate gland for PCa detection. Our hypothesis is as follows, (1) clinically significant PCa detection rate by multi-parametric ultrasound targeted biopsy is comparable with multi-parametric MRI targeted biopsy; (2) clinically significant PCa detection rate by either multi-parametric ultrasound targeted biopsy or multi-parametric ultrasound targeted biopsy is higher than standard systematic biopsy. Our secondary outcome also includes the any cancer detection rate and clinically insignificant prostate cancer detection rate.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study Start: 2023-12
• Study First Submitted QC: 2023-12-26
• Last Update Submitted: 2023-12-26
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging (multiparametric ultrasound and multiparametric MRI)	Prostate imaging	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.
Imaging (multiparametric ultrasound and multiparametric MRI)	Prostate biopsy	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Any cancer detection	Up to 12 weeks following imaging	Any cancer at biopsy histopathology. The measurement that will be based on biopsy histopathology.
Clinically insignificant prostate cancer detection	Up to 12 weeks following imaging	Clinically insignificant prostate cancer at biopsy histopathology. The measurement that will be based on biopsy histopathology.

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China