Status:
COMPLETED
A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Prostate Neoplasm
Eligibility:
MALE
18-80 years
Phase:
NA
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 patie...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT04376008
Start Date
May 1 2018
End Date
June 1 2022
Last Update
October 24 2022
Active Locations (1)
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1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000