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

Prostate Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376008
• Other study ID #: IUNU-PC-104
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Procedure:
• Standard prostate biopsy
Transperineal TRUS guided standard prostate biopsy (SB).
• Targeted and standard prostate biopsy
Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy unfinished rates	The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy	1 days
Primary	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
Primary	Hospitalization rate due to biopsy	The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture	7 days post biopsy
Secondary	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
Secondary	Detection rates of PCa	Prostate cancer is considered as: biopsy Gleason score =3+3	30 days post biopsy
Secondary	Biopsy-related complication rates		30 days post biopsy
Secondary	Biopsy time	How much time is used during biopsy	1 days
Secondary	Consistency rate with final pathology	Concordance rate between biopsy and final pathology	30 days post biopsy
Secondary	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
Secondary	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