Prostate Neoplasm
Conditions
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.
Interventions
PROCEDUREStandard prostate biopsy
Transperineal TRUS guided standard prostate biopsy (SB).
PROCEDURETargeted and standard prostate biopsy
Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Biopsy time | 1 days | How much time is used during biopsy |
| Consistency rate with final pathology | 30 days post biopsy | Concordance rate between biopsy and final pathology |
| 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 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 |
| 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 |
| 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 | — |
Countries
China
Outcome results
None listed