A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia

Study Overview
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Brief Summary
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This trial aims to prospectively assess the feasibility, complications and functional results of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large group of patients.

Detailed Description
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12-core transrectal ultrasound (TRUS) biopsy is one of the most performed urological procedures and remains the standard method for prostate cancer (PCa) histological diagnosis according to the most recent Guidelines. During the last decade, the transperineal prostate biopsy has attracted renewed interest. However, only a few studies and no large prospective studies investigated complications of the transperineal approaches. Image fusion of Multi-parameter MRI (mpMRI) and TRUS guided prostate targeted biopsy had equivalent results with standard 12-core biopsy. Combination of targeted and standard biopsy was recommended in recent Guidelines. Image fusion targeted biopsy needs satisfactory anesthetic effect, and no prospective studies investigated feasibility in this approach under local anesthesia. The scientific urological community is focusing on detection rate and concordance with final pathology of the radical prostatectomy specimen, which remain the cornerstones to assess the accuracy of a prostate biopsy technique. In this study, the investigators will additionally assess the functional results of erectile function and urinary function. Together, the investigators will perform free-hand image fusion targeted biopsies plus standard biopsies under local anesthesia in patients recruited in this study. Then, Feasibility, such as peri-procedural pain, changes in patients quality of life; complications, such as infection rate and bleeding rate; functional results, such as erectile function and urinary function; and concordance with final pathology will be evaluated.

Official Title
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Evaluation of Feasibility, Complications And Functional Results Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia: A Prospective Study

Conditions
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Prostate Neoplasm

Intervention / Treatment
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* Procedure: Standard prostate biopsy
* Procedure: Targeted and standard prostate biopsy


Participation Criteria
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Eligibility Criteria
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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; 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.

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

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PI-RADS 1-2<br>Standard prostate biopsy | Procedure: Standard prostate biopsy<br>* Transperineal TRUS guided standard prostate biopsy (SB).<br>|
| Experimental: PI-RADS 3-5<br>Targeted and standard prostate biopsy | Procedure: Targeted and standard prostate biopsy<br>* Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy unfinished rates | The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy | 1 days | 
| Pain score | Numerical pain scale score during biopsy, the minimum to maximum value is 0 to 10, and higher scores mean a worse outcome | 3 days peri-biopsy | 
| Hospitalization rate due to biopsy | The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture | 7 days post biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rates of clinically significant PCa | Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm. | 30 days post biopsy | 
| Detection rates of PCa | Prostate cancer is considered as: biopsy Gleason score ≥3+3 | 30 days post biopsy | 
| Biopsy-related complication rates |  | 30 days post biopsy | 
| Biopsy time | How much time is used during biopsy | 1 days | 
| Consistency rate with final pathology | Concordance rate between biopsy and final pathology | 30 days post biopsy | 
| international index of erectile function-5 (IIEF-5) score | pre- and post-procedural erectile function score, the minimum to maximum value is 0 to 25, and higher scores mean a better outcome | 30 days post biopsy | 
| International prostate symptom score (IPSS) | pre- and post-procedural urinary function score, the minimum to maximum value is 0 to 35, and higher scores mean a worse outcome | 30 days post biopsy |