PROSTATE CANCER Clinical Trial
— TRUSVSMPMRIOfficial title:
A Prospective Cohort Study Comparing Multi-parametric Ultrasound Versus Multi-parametric MRI for Clinically Significant Prostate Cancer Detection
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinically significant prostate cancer detection | 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. | Up to 12 weeks following imaging | |
Secondary | Any cancer detection | Any cancer at biopsy histopathology. The measurement that will be based on biopsy histopathology. | Up to 12 weeks following imaging | |
Secondary | Clinically insignificant prostate cancer detection | Clinically insignificant prostate cancer at biopsy histopathology. The measurement that will be based on biopsy histopathology. | Up to 12 weeks following imaging |
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