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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Procedure: MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy; Procedure: Cognitive registration targeted biopsy and TRUS-system biopsy

• Registration Number: NCT04953351
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07
• Study Start: 2021-08
• Primary Completion: 2022-02
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 470

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI-ultrasound fusion targeted biopsy	MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy	-
cognitive registration targeted biopsy	Cognitive registration targeted biopsy and TRUS-system biopsy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading	60 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
Detection rates of clinically significant PCa in SB	When histology results available, at an expected average of 30 days post-biopsy
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
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

Trial Locations

Locations (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University; 🇨🇳 Nanjing, Jiangsu, China