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

Prostate Cancer (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880681
• Other study ID #: double needle
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2023
• Source: Region Skane
• Contact: Andreas Forsvall
• Phone: 0046-42-4063121
• Email: andreas.forsvall[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasms
• Prostate Cancer (Diagnosis)
• Prostatic Neoplasms

Intervention

Device:
• Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.
Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
• 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)
Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.

Locations

Country	Name	City	State
Sweden	Helsingborg Hospital	Helsingborg	Scania

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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 t — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain from biopsy sampling	Numeric rating Pain Scale rating from 0-10	At the time of biopsy sampling
Other	14 day complications	Any complications related to the biopsy (example infection, bleeding)	14 days after biopsy
Other	30 day complications	Any complications related to the biopsy (example infection, bleeding)	30 days after biopsy
Primary	Prostate biopsy length (measured by pathologist)	Length of biopsy specimen in millimeters	within 21 days post biopsy
Secondary	Prostate biopsy fragmentation	The number of sections the biopsy specimen is made of	within 21 days post biopsy
Secondary	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
Secondary	Prostate biopsy length (measured in biopsy needle chamber)	Length of biopsy specimen in millimeters	within 21 days post biopsy
Secondary	Prostate biopsy length (measured after removal from biopsy chamber)	Length of biopsy specimen in millimeters	within 21 days post biopsy

External Links

•   Forsvall et al, Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsy
•   Forsvall et al. Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial.