Clinical trial NCT04091230: New Biopsy Needle - Evaluation of Prostate Biopsy Quality
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer (Diagnosis)
Keywords: biopsy quality
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: prostate biopsy length (measured by pathologist)
timeFrame: within 21 days post biopsy
Secondary outcomes:
measure: prostate biopsy fragmentation
timeFrame: within 21 days post biopsy
measure: General appearance of biopsy assessed by pathologist (biopsy quality)
timeFrame: within 21 days post biopsy
measure: prostate biopsy length (measured in biopsy needle chamber)
timeFrame: within 21 days post biopsy
measure: prostate biopsy length (measured in after removal from biopsy chamber)
timeFrame: within 21 days post biopsy
Other outcomes:
measure: patient experience / pain
timeFrame: at the time of rectal ultrasound probe insertion, estimated to a timeframe of 5-30 seconds.
measure: patient experience / pain
timeFrame: at the time of injection needle advancement and periprostatic injection of local anesthesia, estimated to a timeframe of 5-10 seconds
measure: patient experience / pain
timeFrame: at the time of biopsy sampling.
measure: 14 day complications
timeFrame: 14 days
measure: 30 day complications
timeFrame: 30 days
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
state: Scania
Study officials:
affiliation: Lund University
name: Adam Linder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: