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More info
You can access this
clinical trial
if you have
Prostate Cancer
and you are
-
The phase for this study is not defined.
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The purpose

Background: Prostate biopsies are usually performed due to accidentally discovered elevated prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal ultrasound (TRUS) guided biopsy is standard procedure, but possibility for precise documentation concerning the localization of the biopsies are lacking. Therefore, the same locations might be subject to multiple negative biopsies. There is a growing confidence that magnetic resonance imaging (MRI) of the prostate gland can identify significant, high-grade tumours, and studies have shown value in performing MRI before biopsies. Because image documentation is lacking, it is not possible to know which region actually being biopsied with conventional TRUS biopsy. MRI and 3D ultrasound soft image fusion guided biopsy, is a new promising method that will ascertain all regions of the prostate gland to be biopsied, and it is possible to perform accurate targeted biopsies when combined with MRI. Aims of the study Compare the biopsy results in the two groups: 1. To evaluate the overall rate of positive biopsies. 2. To evaluate the rate of re-biopsies. 3. To evaluate the detection rate of Gleason grade 4 and 5 tumours. 4. To evaluate the rate of positive targeted biopsies. 5. To evaluate the rate of positive random biopsies 6. To compare targeted and random biopsies between groups. 7. To compare patient tolerance, time consumption and cost of the two methods. 8. To evaluate the diagnostic accuracy of performing cytological imprints of targeted biopsies. Material and methods: A prospective randomized study including 300 consecutive patients referred to the initial biopsy. The patients are randomized to conventional TRUS biopsies and image fusion guided biopsy. All patients undergo a minimum 12-core re-biopsy procedure. In addition a targeted biopsy will be obtained in case of positive MRI of ultrasound.

Provided treatments

  • Procedure: Biopsies using image fusion
  • Procedure: Gold standard biopsy

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01455792. The sponsor of the trial is Oslo University Hospital and it is looking for 200 volunteers for the current phase.
Official trial title:
MRI and Ultrasound Soft Image Fusion Guided Biopsies Compared to Gold Standard Prostate Biopsies