Prostate Cancer
Conditions
Brief summary
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted 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 (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear. This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
Interventions
PROCEDURECognitive registration targeted biopsy and TRUS-system biopsy
Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.
PROCEDUREMRI-ultrasound fusion targeted biopsy and TRUS-system biopsy
MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
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. 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 V2.1 score ≥3； 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; 5. Men in whom artifact would reduce the quality of the MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rates of clinically significant PCa in FUS-TB and COG-TB | When histology results available, at an expected average of 30 days post-biopsy |
Secondary
| Measure | Time frame |
|---|---|
| Detection rates of clinically insignificant PCa in men with MRI score 3, 4 or 5 | When histology results available, at an expected average of 30 days post-biopsy |
| Cancer core length of the most involved biopsy core (maximum cancer core length) | When histology results available, at an expected average of 30 days post-biopsy |
| Detection rates of clinically insignificant PCa in FUS-TB and COG-TB | When histology results available, at an expected average of 30 days post-biopsy |
| Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading | 60 days post biopsy |
| Detection rates of clinically significant PCa in SB | When histology results available, at an expected average of 30 days post-biopsy |
| Biopsy-related adverse events | 30 days post biopsy |
Countries
China
Contacts
Primary ContactHongqian Guo, PhD
Backup ContactQun Lu, PhD
Outcome results
None listed