Prostate Cancer
Conditions
Keywords
Prostate cancer, MR-target Biopsy, Artemis
Brief summary
This paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that additional MRI-targeted biopsy will detect more clinically significant cancers than standard TRUS biopsy. Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of clinically significant prostate cancer.
Detailed description
Before prostate biopsy, all patients be preceded by mpMRI. The mpMRI is read by an experienced radiologist according to the PI-RADS version 2 scoring system. PI-RADS scoring system is used to assign a degree of doubt prostate cancer. Depending on the PI-RADS score, MR targeted biopsy is determined. 1. MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist. 2. Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.
Interventions
DEVICEArtemia
Before prostate biopsy, all patients be preceded by mpMRI.MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
Sponsors
Bumjin Lim
Dalsan Yoo
Hyung Keun Park
Jun Hyuk Hong
Hanjong Ahn
Choung-Soo Kim
Kye Jin Park
Mi-Hyun Kim
Jeong Kon Kim
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Men undergoing a first-time prostate biopsy to rule out cancer * 2\. Serum PSA ≥3ng/mL, ≤20ng/mL * 3\. Age≥50 years, ≤80 years * 4\. Clinical stage ≤T2c * 5\. Patients must be able to provide written informed consent.
Exclusion criteria
* 1\. Patients has any prior needle biopsy of the prostate * 2\. Patients has a prior history of prostate cancer * 3\. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy * 4\. Patients has a prior history of BPH operation * 5\. Patient with uncorrectable coagulopathies * 6\. Unable to tolerate a TRUS guided biopsy. * 7\. Patients had 5-alpha reductase inhibitor in the past six months. * 8\. The patient has had a urinary tract infection or acute prostatitis in the last three months. * 9\. Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR ≤50mls/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of clinically significant prostate cancer (≥Gleason score 3+4) | 2 week after the procedure |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of men in whom mpMRI score (PI-RADS) for suspicion of clinically significant cancer was 3, 4 or 5 | 2 week after the procedure |
| Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer | 2 week after the procedure |
| Cancer core length of the most involved biopsy core (maximum cancer core length, mm) | 2 week after the procedure |
| Proportion of clinically insignificant prostate cancer (Gleason score 6) | 2 week after the procedure |
| Proportion of Gleason grade upgrading in men undergoing radical prostatectomy | 2 week after the surgery |
| Adverse events of post-biopsy (pain, infection, bleeding etc.) | 2 week after the procedure |
| Inter-observer variability among radiologists | 2 week after the procedure |
| Proportion of men who go on to definitive local treatment or systemic treatment | 2 week after the procedure |
Countries
South Korea
Contacts
Primary ContactIn Gab Jeong, MD, PhD
Outcome results
None listed