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Biopsy Study Comparing MRI and Ultrasound Soft Image Fusion Guided Biopsies and Gold Standard Prostate Biopsies.

NCT01455792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-12-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Biopsies using image fusion

MRI and soft image fusion guided biopsy

PROCEDURE

Gold standard biopsy

Gold standard TRUS biopsy

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Erik Rud, MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455792 on ClinicalTrials.gov