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

July 1, 2021 updated by: Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

PROMUC Trial-Comparison of Magnetic Resonance Imaging-Ultrasound Fusion and Cognitive Registration in MR-targeted Prostate Biopsy: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cognitive registration targeted biopsy
Procedure: 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.
Active Comparator: MRI-ultrasound fusion targeted biopsy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection rates of clinically significant PCa in FUS-TB and COG-TB
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
When histology results available, at an expected average of 30 days post-biopsy

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection rates of clinically insignificant PCa in FUS-TB and COG-TB
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
When histology results available, at an expected average of 30 days post-biopsy
Detection rates of clinically insignificant PCa in men with MRI score 3, 4 or 5
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
When histology results available, at an expected average of 30 days post-biopsy
Cancer core length of the most involved biopsy core (maximum cancer core length)
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
When histology results available, at an expected average of 30 days post-biopsy
Biopsy-related adverse events
Time Frame: 30 days post biopsy
30 days post biopsy
Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading
Time Frame: 60 days post biopsy
60 days post biopsy
Detection rates of clinically significant PCa in SB
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
When histology results available, at an expected average of 30 days post-biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Study Chair: Hongqian Guo, Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRITB-202003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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