Text Size

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

This study is currently recruiting participants.
Verified December 2012 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Erik Rud, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01455792
First received: September 20, 2011
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  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.


Condition Intervention
Prostate Cancer
 Procedure: Biopsies using image fusion
Procedure: Gold standard biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MRI and Ultrasound Soft Image Fusion Guided Biopsies Compared to Gold Standard Prostate Biopsies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Cancer detection rate in the two groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    1. Gold standard TRUS biopsies (random biopsies, targeted and overall)
    2. MRI and TRUS fusioned biopsies (random, targeted and overall)


Secondary Outcome Measures:
  • Detection rate of Gleason grade 4 and 5 tumors in the two groups [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Positive biopsies will be classified according to Gleason score.

  • Total length of biopsies and cancer involvement for targeted, random and all biopsies in both groups [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    The length and cancer involvement will be measured of each biopsy

  • Patient experience of pain during the biopsy and subjective patients perceptions of durations of the biopsy procedure [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    All patients will answer a questionnaire after the procedure.

  • Difference in biopsy yield for Urologist 1 and Urologist 2 performing the gold standard biopsies [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    As two different urologists are performing all gold standard biopsies, the results will be compared.


Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455792

Contacts
Contact: Erik Rud, MD +4722894411 p.e.rud@medisin.uio.no
Contact: Eduard Baco, MD +4722400000 eduard.baco@oslo-universitetssykehus.no

Locations
Norway
Oslo University Hospital, Aker Recruiting
Oslo, Norway, 0514
Contact: Erik Rud, MD     93445684     p.e.rud@medisin.uio.no    
Sub-Investigator: Eduard Baco, MD            
Sub-Investigator: Dagmar Klotz, MD            
Sub-Investigator: Aud Svindland, MD PhD            
Sub-Investigator: Heidi Eggesbø, MD, PhD            
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Erik Rud, MD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Erik Rud, Attending radiologist, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01455792     History of Changes
Other Study ID Numbers: S-09143c2009/2183
Study First Received: September 20, 2011
Last Updated: December 10, 2012
Health Authority: Norway: Ethics Committee

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013