Prostate Neoplasm
Conditions
Brief summary
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mpMRI-targeted biopsy compared to transperineal standard biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.
Detailed description
Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa). With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-biopsy (SB). This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of TB compared to SB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
Interventions
PROCEDURETargeted prostate biopsy
MRI-guided targeted prostate biopsy
PROCEDUREStandard biopsy
Transperineal ultrasound guided prostate biopsy(SB).
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months; 4. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; 5. mpMRI PI-RADS V2 score 4 or 5； 6. 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, estimated glomerular filtration rate ≤ 50mls/min); 4. Contraindication to prostate biopsy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection rates of clinically insignificant PCa | 30 days post biopsy | Clinically insignificant prostate cancer is considered as: biopsy Gleason score \<3+4 and maximum cancer core length \<5 mm. |
| Biopsy-related adverse events | 30 days post biopsy | — |
| Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading | 90 days post-biopsy | Comparing the Gleason grades (from 1-5, the bigger the worse) between biopsy and final pathology, Gleason grade is upgrading when the Gleason grade of final pathology is bigger than that of biopsy. |
Countries
China
Contacts
Primary ContactHongqian Guo, PhD
Backup ContactJie Gao, Bachelor
Outcome results
None listed