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Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| novel needle | Experimental | TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient. |
|
| standard tru cut needle | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRUSbx | Device | Trans Rectal UltraSound guided Prostate Biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| prostate biopsy length (measured by pathologist) | Length of biopsy specimen in millimeters | within 21 days post biopsy |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| patient experience / pain | Numeric rating Pain Scale rating from 0-10 | at the time of rectal ultrasound probe insertion, estimated to a timeframe of 5-30 seconds. |
| patient experience / pain | Numeric rating Pain Scale rating from 0-10 |
Inclusion Criteria:
Exclusion Criteria:
Prostate Biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Adam Linder, MD, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsingborg Hospital | Helsingborg | Skåne County | 254 37 | Sweden |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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Patient and pathologist are unaware of which needle/device is used. TRUSbx are taken from behind the back of the patient enabling masking from the patient.
| 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 |
| at the time of injection needle advancement and periprostatic injection of local anesthesia, estimated to a timeframe of 5-10 seconds |
| patient experience / pain | Numeric rating Pain Scale rating from 0-10 | at the time of biopsy sampling. |
| 14 day complications | Any complications related to the biopsy (example infection, bleeding) | 14 days |
| 30 day complications | Any complications related to the biopsy (example infection, bleeding) | 30 days |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |