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

NCT01455792 | Completed DMC

• 1 other identifier: S-09143c2009/2183
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the overall rate of positive biopsies.
2. 2.To evaluate the rate of re-biopsies.
3. 3.To evaluate the detection rate of Gleason grade 4 and 5 tumours.
4. 4.To evaluate the rate of positive targeted biopsies.
5. 5.To evaluate the rate of positive random biopsies
6. 6.To compare targeted and random biopsies between groups.
7. 7.To compare patient tolerance, time consumption and cost of the two methods.
8. 8.To evaluate the diagnostic accuracy of performing cytological imprints of targeted biopsies.

Conditions

Prostate Cancer

Keywords

Biopsy; MRI and ultrasound soft image fusion; Gold standard TRUS biopsy

Outcome Measures

Primary Outcomes (1)

• Cancer detection rate in the two groups

  1. Gold standard TRUS biopsies (random biopsies, targeted and overall) 2. MRI and TRUS fusioned biopsies (random, targeted and overall)

  Day 1

Secondary Outcomes (4)

• Detection rate of Gleason grade 4 and 5 tumors in the two groups

  Day 1

• Total length of biopsies and cancer involvement for targeted, random and all biopsies in both groups

  day 1

• Patient experience of pain during the biopsy and subjective patients perceptions of durations of the biopsy procedure

  day 1

• Difference in biopsy yield for Urologist 1 and Urologist 2 performing the gold standard biopsies

  day 1

Study Arms (2)

MRI and soft image fusion biopsy

EXPERIMENTAL

Preoperative MRI and soft image ultrasound guided biopsy.

Procedure: Biopsies using image fusion

Gold standard biopsy

ACTIVE COMPARATOR

Gold standard TRUS biopsy

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

Interventions

Biopsies using image fusion PROCEDURE

MRI and soft image fusion guided biopsy

Also known as: Urostation,Koelis,Grenoble, France

Gold standard biopsy; MRI and soft image fusion biopsy

Gold standard biopsy PROCEDURE

Gold standard TRUS biopsy

Also known as: Gold standard

Gold standard biopsy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Aker

Oslo, 0514, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Erik Rud, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending radiologist

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: October 20, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

NO (1)