Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy

Study Overview
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Brief Summary
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This is a randomized controlled and non-inferiority trial in comparison of the novel three-dimensional matrix positioning cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men without a prior biopsy.

Detailed Description
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This trial is a prospective, single-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether a novel three-dimensional matrix positioning cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men without a prior biopsy.

Official Title
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Non-inferiority Randomized Controlled Trial of Novel Three-dimensional Matrix Positioning Based Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: cognitive fusion targeted biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 PSA increase to 4-20 ng/ml and/or abnormal DRE; First time to recive prostate biopsy Sign the informed consent Exclusion Criteria: Have a prostate biopsy before Have acute or chronic prostatitis Contraindications to prostate biopsy Contraindications to MRI Other reasons that not suitable for this trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive targeted biopsy<br>a novel three-dimensional matrix positioning based cognitive fusion targeted biopsy combined with a standard 20-region template guided biopsy | Procedure: cognitive fusion targeted biopsy<br>* A novel three-dimensional matrix positioning based cognitive fusion targeted biopsy<br>|
| Active Comparator: software targeted biopsy<br>software-based fusion targeted biopsy combined with a standard 20-region template guided biopsy | Procedure: cognitive fusion targeted biopsy<br>* A novel three-dimensional matrix positioning based cognitive fusion targeted biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection rate of clinically significant prostate cancer for targeted biopsy | The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples | 5-6 weeks after signing the consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection rate of any prostate cancer for targeted biopsy | The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples | 5-6 weeks after signing the consent | 
| The detection rate of clinically significant prostate cancer for combined biopsy | The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined biopsy samples | 5-6 weeks after signing the consent | 
| The detection rate of any prostate cancer for combined biopsy | The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined biopsy samples | 5-6 weeks after signing the consent | 
| Prostate volume | To measure the prostate volume by ultrasound and MRI | 5-6 weeks after signing the consent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, cognitive fusion targeted biopsy, software-based fusion targeted biopsy