NCT04880681

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer (Diagnosis)

Interventions

Type	Name	Description
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.
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)	Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.

Timeline

• Start date: 2021-05-17
• Primary completion: 2023-12-30
• Completion: 2024-02-28
• First posted: 2021-05-11
• Last updated: 2023-05-01

Locations

1 site across 1 country: Sweden