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

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Artemia


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI tartget biopsy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of clinically significant prostate cancer (≥Gleason score 3+4) |  | 2 week after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of Gleason grade upgrading in men undergoing radical prostatectomy |  | 2 week after the surgery | 
| Adverse events of post-biopsy (pain, infection, bleeding etc.) |  | 2 week after the procedure | 
| Inter-observer variability among radiologists |  | 2 week after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, MR-target Biopsy, Artemis