Spots Global Cancer Trial Database for Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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 ID: NCT04880681

Conditions

Prostate Cancer (Diagnosis)

Interventions

Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.

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)

Study Description

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.