Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal

Study Overview
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Brief Summary
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This prospective study of comparing between Transrectal and transperineal prostate MRI targeted biopsy to provide evidence for clinicians to select the appropriate biopsy approach under different conditions.

Detailed Description
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This prospective study of comparing transperineal (TP) prostate MRI targeted biopsy with transrectal (TR) prostate MRI targeted biopsy was aimed to provide evidence for clinicians to select the appropriate biopsy approach under different conditions. TP (n = 75) and TR (n = 75) will be performed randomly for 150 patients who are suspicious of prostate cancer (PCa). The cancer detection rate (CDR), complication rate, visual analog scale (VAS) score, most painful procedure, number of repeated biopsy and additional anesthesia, and operating time (starting from lying down on the operating table to getting up) will be recorded.

Official Title
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Randomized Controlled Trial of MRI Target Biopsy: Transrectal vs. Transperineal

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Trans-rectal MRI targeted Biopsy
* Procedure: Trans-perineal MRI targeted Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prostate-specific antigen > 4ng/ml Palpation is positive Exclusion Criteria: older than 80y prostate-specific antigen > 100 ng/ml

Ages Eligible for Study
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Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trans-rectal MRI targeted Biopsy<br>Trans-rectal to perform the prostate MRI targeted biopsy The puncture points are at the rectal | Procedure: Trans-rectal MRI targeted Biopsy<br>* Trans-rectal biopsy of the prostate: A procedure in which a sample of tissue is removed from the prostate using a thin needle that is inserted through the rectum and into the prostate.<br>|
| Active Comparator: Trans-perineal MRI targeted Biopsy<br>Trans-perineal to perform the prostate MRI targeted biopsy The puncture points are at the perineal | Procedure: Trans-perineal MRI targeted Biopsy<br>* Trans-perineal biopsy of the prostate: The sample is removed with a thin needle that is inserted through the skin of the perineum and into the prostate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of positive detections | the rate of positive detections (How many case are Prostate cancer positive) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence rate of each complication | the Incidence of complication rate is the number of complications divided by the number of patients and the number of patients with complications. Complications were separated into those with major or minor sequelae and the proportion of each type that were due to medical error (avoidable). | 1 year |