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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01455792
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : December 30, 2013
Information provided by (Responsible Party):
Erik Rud, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Biopsies using image fusion Procedure: Gold standard biopsy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI and Ultrasound Soft Image Fusion Guided Biopsies Compared to Gold Standard Prostate Biopsies
Study Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Experimental: MRI and soft image fusion biopsy
Preoperative MRI and soft image ultrasound guided biopsy.
Procedure: Biopsies using image fusion
MRI and soft image fusion guided biopsy
Other Name: Urostation,Koelis,Grenoble, France
Active Comparator: Gold standard biopsy
Gold standard TRUS biopsy
Procedure: Biopsies using image fusion
MRI and soft image fusion guided biopsy
Other Name: Urostation,Koelis,Grenoble, France
Procedure: Gold standard biopsy
Gold standard TRUS biopsy
Other Name: Gold standard

Primary Outcome Measures :
  1. Cancer detection rate in the two groups [ Time Frame: Day 1 ]
    1. Gold standard TRUS biopsies (random biopsies, targeted and overall)
    2. MRI and TRUS fusioned biopsies (random, targeted and overall)

Secondary Outcome Measures :
  1. Detection rate of Gleason grade 4 and 5 tumors in the two groups [ Time Frame: Day 1 ]
    Positive biopsies will be classified according to Gleason score.

  2. Total length of biopsies and cancer involvement for targeted, random and all biopsies in both groups [ Time Frame: day 1 ]
    The length and cancer involvement will be measured of each biopsy

  3. Patient experience of pain during the biopsy and subjective patients perceptions of durations of the biopsy procedure [ Time Frame: day 1 ]
    All patients will answer a questionnaire after the procedure.

  4. Difference in biopsy yield for Urologist 1 and Urologist 2 performing the gold standard biopsies [ Time Frame: day 1 ]
    As two different urologists are performing all gold standard biopsies, the results will be compared.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion criteria

  • Patients without previous biopsies.
  • Men aged < 75 years, in whom it is clinically relevant to decide whether he has prostate cancer.
  • PSA > 3 - 4 ng/ml and < 20 ng/ml.
  • Suspicious findings on DRE or TRUS.
  • Informed consent.

Exclusion criteria

  • Patients who refuse to sign the consent form for any reason or do not accept the study premises.
  • Patients who want to withdraw for any reason during the study.
  • Patients with contraindications to MRI (pacemaker, claustrophobia etc.)
  • Patients who have already undergone a high quality MRI examination of the prostate within the last year. In this situation the MRI examination will be evaluated together with the surgeon and radiologist on an individual basis. In case of a low quality examination, we will disregard the findings, and include the patient.

An accurate record will be kept of all the excluded patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01455792

Oslo University Hospital, Aker
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Erik Rud, MD Oslo University Hospital

Responsible Party: Erik Rud, Attending radiologist, Oslo University Hospital Identifier: NCT01455792     History of Changes
Other Study ID Numbers: S-09143c2009/2183
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by Erik Rud, Oslo University Hospital:
MRI and ultrasound soft image fusion
Gold standard TRUS biopsy