Prostate Cancer
Conditions
Interventions
MRI-TRUS fusion (experiment group):The mpMRI and transrectal ultrasound are performed on patients and the images are fused by Venus Plus PRO. Then we conduted 4 transperineal targeted biospy with need
cognitive fusion (control group):The mpMRI and transrectal ultrasound are performed on patients and the images are fused by experienced doctors. Then we conduted 4 transperineal targeted biospy with n
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) male who are between 18 to 80 years old; 2) meet any of the following criteria: a) suspicious nodules of prostate under digital rectal examination(DRE), with any PSA value; b) PSA=10µg/L; c) 4µg/L=PSA<10µg/L,f/t PSA=0.16; 3) suspicious lesions under mpMRI, at least one lesion <5mm, PI-RADS 4; 4) good compliance; 5) must sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) diagnosed prostate cancer or acute prostatitis; 2) acute infection, or clinically significant urinary tract infection; 3) performed prostate puncture within 1 month; 4) cardiac insufficiency; 5) having high risk of bleeding or taking anticoagulants for a long time; 6) severe internal or external hemorrhoids, perianal or rectal lesions; 7) having severe osteoarticular diseases that can not be performed lithotomy; 8) hypertensive crisis; 9) patients who should not be anesthetized; 10) patients with mental illness or mental disorders and unable to understand the informed consent; 11) patients with electronic devices such as built-in artificial pacemaker, cochlear implants or nerve stimulators; 12) other surgical contraindications, or those considered unsuitable by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| detection rate of any PCa; | — |
Secondary
| Measure | Time frame |
|---|---|
| detection rate(cs PCa and PCa) of TBx;detection rate(cs PCa and PCa) of TBx under cognitive fusion;detection rate(cs PCa and PCa) of TBx under MRI-TRUS fusion;detection rate for PI-RADS 4 small lesion (<5mm) under cognitive fusion;detection rate for PI-RADS 4 small lesion (<5mm) under MRI-TRUS fusion; | — |
Countries
China
Contacts
Public ContactWang Shangqian
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed