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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320147
• Other study ID #: MRphI_AMC01
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2020
• Source: Asan Medical Center
• Contact: In Gab Jeong, MD, PhD
• Phone: 82-2-3010-5892
• Email: igjeong[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Artemia
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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (10)

Lead Sponsor	Collaborator
Asan Medical Center	Bumjin Lim, Choung-Soo Kim, Dalsan Yoo, Hanjong Ahn, Hyung Keun Park, Jeong Kon Kim, Jun Hyuk Hong, Kye Jin Park, Mi-Hyun Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of clinically significant prostate cancer (=Gleason score 3+4)		2 week after the procedure
Secondary	Proportion of clinically insignificant prostate cancer (Gleason score 6)		2 week after the procedure
Secondary	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
Secondary	Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer		2 week after the procedure
Secondary	Cancer core length of the most involved biopsy core (maximum cancer core length, mm)		2 week after the procedure
Secondary	Proportion of men who go on to definitive local treatment or systemic treatment		2 week after the procedure
Secondary	Proportion of Gleason grade upgrading in men undergoing radical prostatectomy		2 week after the surgery
Secondary	Adverse events of post-biopsy (pain, infection, bleeding etc.)		2 week after the procedure
Secondary	Inter-observer variability among radiologists		2 week after the procedure