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