New Biopsy Needle - Evaluation of Prostate Biopsy Quality

Study Overview
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Brief Summary
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Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.

Detailed Description
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Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance. The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today. This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.

Official Title
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Prospective Patient Blinded Randomized Trial Comparing Biopsy Specimen Quality in a Novel Biopsy Needle and Actuator Compared to Todays Standard Tru Cut Needle and Actuator.

Conditions
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Prostate Cancer (Diagnosis)

Intervention / Treatment
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* Device: TRUSbx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for prostate biopsy Signed informed written consent Exclusion Criteria: None (other than general contra indications for prostate biopsy or patient not willing to participate)

Ages Eligible for Study
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Minimum Age: 40 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 20 patients eligible for prostate biopsy are randomized into 2 arms (10+10 patients) using either the novel needle and actuator device or standard tru cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy quality is evaluated by the pathologist blinded to device used.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: novel needle<br>TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient. | Device: TRUSbx<br>* Trans Rectal UltraSound guided Prostate Biopsy<br>* Other names: prostate biopsy;|
| Active Comparator: standard tru cut needle<br>TRUSbx using a standard tru cut biopsy needle (Mermaid Medical M-biopsy 18G 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator ( Moller Medical Blue RBG-1000-10-1000). 12 biopsies/ patient. | Device: TRUSbx<br>* Trans Rectal UltraSound guided Prostate Biopsy<br>* Other names: prostate biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate biopsy length (measured by pathologist) | Length of biopsy specimen in millimeters | within 21 days post biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate biopsy fragmentation | The number of sections the biopsy specimen is made of | within 21 days post biopsy | 
| General appearance of biopsy assessed by pathologist (biopsy quality) | General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent) | within 21 days post biopsy | 
| prostate biopsy length (measured in biopsy needle chamber) | Length of biopsy specimen in millimeters | within 21 days post biopsy | 
| prostate biopsy length (measured in after removal from biopsy chamber) | Length of biopsy specimen in millimeters | within 21 days post biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsy quality