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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04320147
• Collaborator: Bumjin Lim (Other), Dalsan Yoo (Other), Hyung Keun Park (Other), Jun Hyuk Hong (Other), Hanjong Ahn (Other), Choung-Soo Kim (Other), Kye Jin Park (Other), Mi-Hyun Kim (Other), Jeong Kon Kim (Other)
• Enrollment: 300
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36.3
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Artemia	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
• Anticipated Study Start Date: Mar 23, 2020
• Anticipated Primary Completion Date: Apr 1, 2021
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Proportion of clinically significant prostate cancer (≥Gleason score 3+4) [2 week after the procedure]

Secondary Outcome Measures

1. Proportion of clinically insignificant prostate cancer (Gleason score 6) [2 week after the procedure]

2. 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]

3. Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer [2 week after the procedure]

4. Cancer core length of the most involved biopsy core (maximum cancer core length, mm) [2 week after the procedure]

5. Proportion of men who go on to definitive local treatment or systemic treatment [2 week after the procedure]

6. Proportion of Gleason grade upgrading in men undergoing radical prostatectomy [2 week after the surgery]

7. Adverse events of post-biopsy (pain, infection, bleeding etc.) [2 week after the procedure]

8. Inter-observer variability among radiologists [2 week after the procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Men undergoing a first-time prostate biopsy to rule out cancer
• 1. Serum PSA ≥3ng/mL, ≤20ng/mL
• 1. Age≥50 years, ≤80 years
• 1. Clinical stage ≤T2c
• 1. Patients must be able to provide written informed consent.

Exclusion Criteria:

• 1. Patients has any prior needle biopsy of the prostate
• 1. Patients has a prior history of prostate cancer
• 1. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
• 1. Patients has a prior history of BPH operation
• 1. Patient with uncorrectable coagulopathies
• 1. Unable to tolerate a TRUS guided biopsy.
• 1. Patients had 5-alpha reductase inhibitor in the past six months.
• 1. The patient has had a urinary tract infection or acute prostatitis in the last three months.
• 1. Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR ≤50mls/min)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	138-736

Sponsors and Collaborators

• Asan Medical Center
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: In Gab Jeong, Professor, Department of Urology, Asan Medical Center, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT04320147
• Other Study ID Numbers: MRphI_AMC01
• First Posted: Mar 24, 2020
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by In Gab Jeong, Professor, Department of Urology, Asan Medical Center, Asan Medical Center: Prostate cancer; MR-target Biopsy; Artemis
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 25, 2020