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

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Cognitive registration targeted biopsy and TRUS-system biopsy
* Procedure: MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive registration targeted biopsy<br> | Procedure: Cognitive registration targeted biopsy and TRUS-system biopsy<br>* 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.<br>|
| Active Comparator: MRI-ultrasound fusion targeted biopsy<br> | Procedure: MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Detection rates of clinically significant PCa in SB |  | When histology results available, at an expected average of 30 days post-biopsy |