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

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Prostate biopsy fragmentation(within 21 days post biopsy)
• General appearance of biopsy assessed by pathologist (biopsy quality)(within 21 days post biopsy)
• Prostate biopsy length (measured after removal from biopsy chamber)(within 21 days post biopsy)
• Prostate biopsy length (measured in biopsy needle chamber)(within 21 days post biopsy)