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

NCT04320147 | Unknown DMC FDA Device

• 1 other identifier: MRphI_AMC01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; MR-target Biopsy; Artemis

Outcome Measures

Primary Outcomes (1)

• Proportion of clinically significant prostate cancer (≥Gleason score 3+4)

  2 week after the procedure

Secondary Outcomes (8)

• 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

Study Arms (1)

MRI tartget biopsy

EXPERIMENTAL

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.

Device: Artemia

Interventions

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.

MRI tartget biopsy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead
• Bumjin Lim: collaborator
• Dalsan Yoo: collaborator
• Hyung Keun Park: collaborator
• Jun Hyuk Hong: collaborator
• Hanjong Ahn: collaborator
• Choung-Soo Kim: collaborator
• Kye Jin Park: collaborator
• Mi-Hyun Kim: collaborator
• Jeong Kon Kim: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Severe combined immunodeficiency with sensitivity to ionizing radiation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• In Gab Jeong, MD, PhD

  Asan Medical Center

  STUDY CHAIR

Central Study Contacts

In Gab Jeong, MD, PhD

CONTACT

82-2-3010-5892; igjeong@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Urology, Asan Medical Center

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 24, 2020
• Study Start: March 23, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2023
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)