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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,050
Transperineal TRUS guided standard prostate biopsy (SB).
Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Biopsy unfinished rates
The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy
Time frame: 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
Time frame: 3 days peri-biopsy
Hospitalization rate due to biopsy
The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture
Time frame: 7 days post biopsy
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.
Time frame: 30 days post biopsy
Detection rates of PCa
Prostate cancer is considered as: biopsy Gleason score ≥3+3
Time frame: 30 days post biopsy
Biopsy-related complication rates
Time frame: 30 days post biopsy
Biopsy time
How much time is used during biopsy
Time frame: 1 days
Consistency rate with final pathology
Concordance rate between biopsy and final pathology
Time frame: 30 days post biopsy
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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
Time frame: 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
Time frame: 30 days post biopsy