Prostate Core Needle Biopsy

Study Overview
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Brief Summary
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Prostate tissue biopsy is performed with either transrectal or transperineal approach. These two methods are usually based on tissue sampling with an ultrasound-guided core needle biopsy. Transperineal prostate biopsy can be done either with a conventional noncoaxial technique or with a coaxial technique. In conventional transperineal technique, biopsy needle is inserted repeatedly for each tissue sampling. Alternatively, a coaxial needle can be placed over the perineum; then, the direction of the biopsy can be changed by tilting the coaxial needle. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in transperineal prostate biopsy.

Conditions
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Biopsy, Prostate, Complication

Intervention / Treatment
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* Device: coaxial prostate biopsy
* Device: noncoaxial prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: an elevated prostate-specific antigen (PSA) level suspicious digital rectal examination Exclusion Criteria: a history of prostate cancer clinical findings of acute or chronic prostate inflammation a history of urogenital procedures

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transperineal prostate biopsy with coaxial method<br>The patients undergo transperineal biopsy with a coaxial Tru-Cut needle (18-gauge Core Biopsy Instrument with a 17-gauge Disposable Coaxial Needle). | Device: coaxial prostate biopsy<br>* In this method, a larger introducing needle is needed for the puncture. The introducing needle is placed over the perineum. The biopsy needle is inserted throughout the introducing needle.Then, the direction of the biopsy is changed by tilting the coaxial needle. The investigator needs to puncture the prostate capsule only once for sampling at each each side of the prostate (right and left sides).<br>* Other names: coaxial Tru-Cut needle (18-gauge Bard Max-Core Disposable Core Biopsy Instrument, 17-gauge Bard TruGuide Disposable Coaxial Needle; C. R. Bard, Tempe, USA);|
| Experimental: transperineal prostate biopsy with noncoaxial method<br>The patients undergo transperineal biopsy with a noncoaxial 18-gauge needle. | Device: noncoaxial prostate biopsy<br>* In this method, there is no introducing needle. Biopsy needle is inserted repeatedly for each tissue sampling (at least fourteen times). A smaller biopsy needle is used for the puncture in this method. The main disadvantage of the coaxial technique is that a larger introducing needle is needed for the puncture (12). On the other whand, the advantage of noncoaxial method is that the needle is within the prostate for only a few seconds to document needle position with ultrasonography before firing<br>* Other names: noncoaxial 18-gauge needle (Bard Max-Core Disposable Core Biopsy Instrument; C. R. Bard, Tempe, USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication ratio |  | within 48 hours after the procedure |