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

Not Applicable

Recruiting

• Conditions: Prostate Cancer (Diagnosis)
• Interventions: 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); Device: Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.

• Registration Number: NCT04880681
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-11
• Study Start: 2021-05-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Tru Cut needle	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)	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).
Novel needle	Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.	Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.

Primary Outcome Measures

Name	Time	Method
Prostate biopsy length (measured by pathologist)	within 21 days post biopsy	Length of biopsy specimen in millimeters

Secondary Outcome Measures

Name	Time	Method
Prostate biopsy fragmentation	within 21 days post biopsy	The number of sections the biopsy specimen is made of
General appearance of biopsy assessed by pathologist (biopsy quality)	within 21 days post biopsy	General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)
Prostate biopsy length (measured after removal from biopsy chamber)	within 21 days post biopsy	Length of biopsy specimen in millimeters
Prostate biopsy length (measured in biopsy needle chamber)	within 21 days post biopsy	Length of biopsy specimen in millimeters

Trial Locations

Locations (1)

Helsingborg Hospital; 🇸🇪 Helsingborg, Scania, Sweden