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

Nanjing University

Status

Completed

Conditions

Prostate Neoplasm

Treatments

Procedure: Targeted and standard prostate biopsy

Procedure: Standard prostate biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT04376008

IUNU-PC-104

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,050 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.