Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04880681
Study type Interventional
Source Region Skane
Contact Andreas Forsvall
Phone 0046-42-4063121
Email andreas.forsvall@med.lu.se
Status Recruiting
Phase N/A
Start date May 17, 2021
Completion date February 28, 2024

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04803188 - Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I N/A
Completed NCT04091230 - New Biopsy Needle - Evaluation of Prostate Biopsy Quality N/A
Recruiting NCT03507595 - Evaluation of the Metastasis and Recurrence of Prostate Cancer
Not yet recruiting NCT04079699 - Predicting Prostate Cancer in Elderly Men N/A
Completed NCT04583072 - Stockholm3 Validation Study in a Multi-Ethnic Cohort