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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Neoplasm
• Intervention / Treatment: Procedure: Standard prostate biopsy; Procedure: Targeted and standard prostate biopsy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1050
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IUNU-PC-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No