MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer

MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Artemia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: In Gab Jeong, MD, PhD; Phone Number: 82-2-3010-5892; Email: igjeong@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MRI tartget biopsy; MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.; Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.	Device: Artemia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of clinically significant prostate cancer (≥Gleason score 3+4)	2 week after the procedure

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Bumjin Lim; Dalsan Yoo; Hyung Keun Park; Jun Hyuk Hong; Hanjong Ahn; Choung-Soo Kim; Kye Jin Park; Mi-Hyun Kim; Jeong Kon Kim
• Investigators: Study Chair: In Gab Jeong, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 23, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Prostate cancer; MR-target Biopsy; Artemis
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MRphI_AMC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes