Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection

Study Overview
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Brief Summary
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This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mpMRI-targeted biopsy compared to transperineal standard biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

Detailed Description
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Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa). With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-biopsy (SB). This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of TB compared to SB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Official Title
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Diagnostic Efficiency With Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Transperineal Ultrasound-guided Biopsy in Biopsy-naïve Suspicious Prostate Cancer Patients: A Randomized Controlled Trial

Conditions
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Prostate Neoplasm

Intervention / Treatment
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* Procedure: Targeted prostate biopsy
* Procedure: Standard biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men more than 18 years old with clinical suspicion of prostate cancer; Serum PSA ≤ 20 ng/ml within the previous 3 months; Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months; No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; mpMRI PI-RADS V2 score 4 or 5； Able to provide written informed consent. Exclusion Criteria: Prior prostate biopsy or prostate surgery; Prior treatment for prostate cancer; Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); Contraindication to prostate biopsy.

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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No

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: target biopsy group<br>Targeted prostate biopsy | Procedure: Targeted prostate biopsy<br>* MRI-guided targeted prostate biopsy<br>|
| Active Comparator: standard biopsy group<br>Standard prostate biopsy | Procedure: Standard biopsy<br>* Transperineal ultrasound guided prostate biopsy(SB).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rates of clinically significant PCa | Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm. | 30 days post biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rates of clinically insignificant PCa | Clinically insignificant prostate cancer is considered as: biopsy Gleason score <3+4 and maximum cancer core length <5 mm. | 30 days post biopsy | 
| Biopsy-related adverse events |  | 30 days post biopsy | 
| Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading | Comparing the Gleason grades (from 1-5, the bigger the worse) between biopsy and final pathology, Gleason grade is upgrading when the Gleason grade of final pathology is bigger than that of biopsy. | 90 days post-biopsy |