Clinical trial NCT06183905: Multi-parametric Ultrasound Versus Multi-parametric MRI for Prostate Cancer Detection
Official title: A Prospective Cohort Study Comparing Multi-parametric Ultrasound Versus Multi-parametric MRI for Clinically Significant Prostate Cancer Detection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PROSTATE CANCER
Prostate Biopsy
Keywords: prostate cancer
multiparametric ultrasound
multiparametric MRI
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 500
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: clinically significant prostate cancer detection
timeFrame: Up to 12 weeks following imaging
Secondary outcomes:
measure: Any cancer detection
timeFrame: Up to 12 weeks following imaging
measure: Clinically insignificant prostate cancer detection
timeFrame: Up to 12 weeks following imaging
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Yunkai Zhu
role: PRINCIPAL_INVESTIGATOR
References: