MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy

NCT ID: NCT04953351

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-07-31

Brief Summary

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

Detailed Description

Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).

With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear.

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

cognitive registration targeted biopsy

Group Type: EXPERIMENTAL

Cognitive registration targeted biopsy and TRUS-system biopsy

Intervention Type: PROCEDURE

Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.

MRI-ultrasound fusion targeted biopsy

Group Type: ACTIVE_COMPARATOR

MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy

Intervention Type: PROCEDURE

MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.

Interventions

Cognitive registration targeted biopsy and TRUS-system biopsy

Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.

Intervention Type: PROCEDURE

MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy

MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Men more than 18 years old with clinical suspicion of prostate cancer;

2. Serum PSA ≤ 20 ng/ml within the previous 3 months;

3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;

4. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;

5. mpMRI PI-RADS V2.1 score ≥3；

6. Able to provide written informed consent.

Exclusion Criteria

1. Prior prostate biopsy or prostate surgery;

2. Prior treatment for prostate cancer;

3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);

4. Contraindication to prostate biopsy;

5. Men in whom artifact would reduce the quality of the MRI.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hongqian Guo

Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongqian Guo, Guo

Role: STUDY_CHAIR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Hongqian Guo, PhD

Role: CONTACT

dr.ghq@nju.edu.cn

8613605171690

Qun Lu, PhD

Role: CONTACT

luqun_1989@126.com

8615195856020

Other Identifiers

MRITB-202003

Identifier Type: -

Identifier Source: org_study_id