Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bumjin Lim | UNKNOWN |
| Dalsan Yoo | UNKNOWN |
| Hyung Keun Park | UNKNOWN |
| Jun Hyuk Hong |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI tartget biopsy | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemia | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of clinically significant prostate cancer (≥Gleason score 3+4) | 2 week after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of clinically insignificant prostate cancer (Gleason score 6) | 2 week after the procedure | |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| In Gab Jeong, MD, PhD | Contact | 82-2-3010-5892 | igjeong@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| In Gab Jeong, MD, PhD | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| C537589 | Severe combined immunodeficiency with sensitivity to ionizing radiation |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| Hanjong Ahn | UNKNOWN |
| Choung-Soo Kim | UNKNOWN |
| Kye Jin Park | UNKNOWN |
| Mi-Hyun Kim | UNKNOWN |
| Jeong Kon Kim | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 men who go on to definitive local treatment or systemic treatment | 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |