Clinical trial NCT04320147: MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer
Official title: MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
MR-target Biopsy
Artemis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Bumjin Lim
name: Dalsan Yoo
name: Hyung Keun Park
name: Jun Hyuk Hong
name: Hanjong Ahn
name: Choung-Soo Kim
name: Kye Jin Park
name: Mi-Hyun Kim
name: Jeong Kon Kim
First posted: 2020-03-24
Enrollment: 300
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of clinically significant prostate cancer (≥Gleason score 3+4)
timeFrame: 2 week after the procedure
Secondary outcomes:
measure: Proportion of clinically insignificant prostate cancer (Gleason score 6)
timeFrame: 2 week after the procedure
measure: Proportion of men in whom mpMRI score (PI-RADS) for suspicion of clinically significant cancer was 3, 4 or 5
timeFrame: 2 week after the procedure
measure: Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer
timeFrame: 2 week after the procedure
measure: Cancer core length of the most involved biopsy core (maximum cancer core length, mm)
timeFrame: 2 week after the procedure
measure: Proportion of men who go on to definitive local treatment or systemic treatment
timeFrame: 2 week after the procedure
measure: Proportion of Gleason grade upgrading in men undergoing radical prostatectomy
timeFrame: 2 week after the surgery
measure: Adverse events of post-biopsy (pain, infection, bleeding etc.)
timeFrame: 2 week after the procedure
measure: Inter-observer variability among radiologists
timeFrame: 2 week after the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: In Gab Jeong, MD, PhD
role: STUDY_CHAIR
References: