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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Device: Artemia

• Registration Number: NCT04320147
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-19
• Study Start: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-24
• Last Update Posted: 2020-03-25
• Primary Completion: 2021-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI tartget biopsy	Artemia	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Inter-observer variability among radiologists	2 week after the procedure
Proportion of Gleason grade upgrading in men undergoing radical prostatectomy	2 week after the surgery
Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer	2 week after the procedure
Proportion of clinically insignificant prostate cancer (Gleason score 6)	2 week after the procedure
Adverse events of post-biopsy (pain, infection, bleeding etc.)	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
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of