A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia
- Conditions
- Prostate Neoplasm
- Interventions
- Procedure: Targeted and standard prostate biopsyProcedure: Standard prostate biopsy
- Registration Number
- NCT04376008
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1050
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PI-RADS 3-5 Targeted and standard prostate biopsy Targeted and standard prostate biopsy PI-RADS 1-2 Standard prostate biopsy Standard prostate biopsy
- Primary Outcome Measures
Name Time Method Biopsy unfinished rates 1 days The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy
Pain score 3 days peri-biopsy Numerical pain scale score during biopsy, the minimum to maximum value is 0 to 10, and higher scores mean a worse outcome
Hospitalization rate due to biopsy 7 days post biopsy The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture
- Secondary Outcome Measures
Name Time Method Detection rates of clinically significant PCa 30 days post biopsy Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm.
international index of erectile function-5 (IIEF-5) score 30 days post biopsy pre- and post-procedural erectile function score, the minimum to maximum value is 0 to 25, and higher scores mean a better outcome
Consistency rate with final pathology 30 days post biopsy Concordance rate between biopsy and final pathology
Detection rates of PCa 30 days post biopsy Prostate cancer is considered as: biopsy Gleason score ≥3+3
Biopsy-related complication rates 30 days post biopsy Biopsy time 1 days How much time is used during biopsy
International prostate symptom score (IPSS) 30 days post biopsy pre- and post-procedural urinary function score, the minimum to maximum value is 0 to 35, and higher scores mean a worse outcome
Trial Locations
- Locations (1)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China