Prostate Cancer
Conditions
Brief summary
This study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.
Detailed description
This is a single-center prospective study. The investigators perform MRI/US image fusion targeted saturation biopsy on prostate lesions with PI-RADS score 4, to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.
Interventions
PROCEDUREMRI/Ultrasound Fusion Saturation Biopsy
MRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Men more than 18 years old with clinical suspicion of prostate cancer; 2. Serum PSA ≤ 20 ng/ml within the previous 3 months; 3. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; 4. mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm； 5. Able to provide written informed consent.
Exclusion criteria
1. Prior prostate biopsy or prostate surgery; 2. Prior treatment for prostate cancer; 3. Contraindication to MRI (e.g. claustrophobia, pacemaker); 4. Contraindication to prostate biopsy; 5. Men in whom artifact would reduce the quality of the MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area | When histology results available, at an expected average of 3 days post-biopsy |
Countries
China
Contacts
Primary ContactHongqian Guo
Backup ContactQun Lu
Outcome results
None listed