Clinical trial NCT04880681: Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
Official title: Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer (Diagnosis)
Keywords: Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: 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)

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 after removal from biopsy chamber)
timeFrame: within 21 days post biopsy
Other outcomes:
measure: Pain from biopsy sampling
timeFrame: At the time of biopsy sampling
measure: 14 day complications
timeFrame: 14 days after biopsy
measure: 30 day complications
timeFrame: 30 days after biopsy
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
state: Scania
Study officials:
affiliation: Lund University
name: Adam Linder, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forsvall A, Fisher J, Wagenius M, Broman C, Korkocic D, Bratt O, Linder A. Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial. Scand J Urol. 2021 Jun;55(3):235-241. doi: 10.1080/21681805.2021.1921024. Epub 2021 May 17.
citation: Forsvall A, Fisher J, Cardoso JFP, Wagenius M, Tverring J, Nilson B, Dahlin A, Bratt O, Linder A, Mohanty T. Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsy - a novel needle design with the objective to reduce the risk of post-biopsy infection. Scand J Urol. 2021 Jun;55(3):227-234. doi: 10.1080/21681805.2021.1921023. Epub 2021 May 17.