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

Asan Medical Center

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: Artemia

Study type: Interventional

Funder types: Other

Identifiers

NCT04320147

MRphI_AMC01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

MRI tartget biopsy

Experimental group

Description:

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.

Treatment:

Device: Artemia