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

NCT04953351 | Unknown

• 1 other identifier: MRITB-202003
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Detection rates of clinically significant PCa in FUS-TB and COG-TB

  When histology results available, at an expected average of 30 days post-biopsy

Secondary Outcomes (6)

• Detection rates of clinically insignificant PCa in FUS-TB and COG-TB

  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

  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)

  When histology results available, at an expected average of 30 days post-biopsy

• Biopsy-related adverse events

  30 days post biopsy

• Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading

  60 days post biopsy

Study Arms (2)

cognitive registration targeted biopsy

EXPERIMENTAL

Procedure: Cognitive registration targeted biopsy and TRUS-system biopsy

MRI-ultrasound fusion targeted biopsy

ACTIVE COMPARATOR

Procedure: MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy

Interventions

Cognitive registration targeted biopsy and TRUS-system biopsy 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.

cognitive registration targeted biopsy

MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy 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.

MRI-ultrasound fusion targeted biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men more than 18 years old with clinical suspicion of prostate cancer;
• Serum PSA ≤ 20 ng/ml within the previous 3 months;
• Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
• No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
• mpMRI PI-RADS V2.1 score ≥3；
• Able to provide written informed consent.

You may not qualify if:

• Prior prostate biopsy or prostate surgery;
• Prior treatment for prostate cancer;
• Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
• Contraindication to prostate biopsy;
• Men in whom artifact would reduce the quality of the MRI.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210000, China

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

• Hongqian Guo, Guo

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

Hongqian Guo, PhD

CONTACT

8613605171690; dr.ghq@nju.edu.cn

Qun Lu, PhD

CONTACT

8615195856020; luqun_1989@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 7, 2021
• Study Start: August 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

CN (1)