Clinical trial NCT04376008: A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia
Official title: Evaluation of Feasibility, Complications And Functional Results Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Neoplasm
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 1050
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biopsy unfinished rates
timeFrame: 1 days
measure: Pain score
timeFrame: 3 days peri-biopsy
measure: Hospitalization rate due to biopsy
timeFrame: 7 days post biopsy
Secondary outcomes:
measure: Detection rates of clinically significant PCa
timeFrame: 30 days post biopsy
measure: Detection rates of PCa
timeFrame: 30 days post biopsy
measure: Biopsy-related complication rates
timeFrame: 30 days post biopsy
measure: Biopsy time
timeFrame: 1 days
measure: Consistency rate with final pathology
timeFrame: 30 days post biopsy
measure: international index of erectile function-5 (IIEF-5) score
timeFrame: 30 days post biopsy
measure: International prostate symptom score (IPSS)
timeFrame: 30 days post biopsy
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References: