Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle

Study Overview
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Brief Summary
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Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.

Detailed Description
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Prostate biopsy is the golden standard for prostate cancer diagnosis. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. The biopsy chamber of the Tru Cut needle is in general 19 mm. However, it is on average filled only with 13 mm of tissue. Biopsy length is strongly correlated with diagnostic accuracy of prostate cancer. Additionally, TRUSbx has a high risk of infection due to bacteria being brought across the colon wall. The investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (NCT049091230) has shown non inferior biopsy length when compared to the standard Tru Cut needle. A further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. This is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard Tru Cut biopsy needle in prostate biopsy.

Official Title
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Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle

Conditions
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Prostate Cancer (Diagnosis)

Intervention / Treatment
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* Device: Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.
* Device: Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)


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 contraindications for prostate biopsy or patient not willing to participate)

Ages Eligible for Study
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Minimum Age: 40 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: 60 patients eligible for prostate biopsy are randomized into 2 arms (30+30 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 length (primary outcome) is evaluated by a pathologist who is blinded to device used.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel needle<br>Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. | Device: Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.<br>* Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.<br>* Other names: prostate biopsy;|
| Active Comparator: Standard Tru Cut needle<br>Standard tru cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000). | Device: Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)<br>* Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.<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 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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Prostatic Neoplasms, Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Prostatic Diseases