An interventional study of Standard prostate biopsy and Targeted and standard prostate biopsy in Prostate Neoplasm, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Completed at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-24.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,050 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard prostate biopsy
Procedure: Standard prostate biopsy
Targeted and standard prostate biopsy
Procedure: Targeted and standard prostate biopsy
Transperineal TRUS guided standard prostate biopsy (SB).
Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).
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
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
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School