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.

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.

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)