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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Artemia
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, MR-target Biopsy, Artemis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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)

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI tartget biopsy

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of clinically significant prostate cancer (≥Gleason score 3+4)

Secondary Outcome Measures

Proportion of clinically insignificant prostate cancer (Gleason score 6)
Proportion of men in whom mpMRI score (PI-RADS) for suspicion of clinically significant cancer was 3, 4 or 5
Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer
Cancer core length of the most involved biopsy core (maximum cancer core length, mm)
Proportion of men who go on to definitive local treatment or systemic treatment
Proportion of Gleason grade upgrading in men undergoing radical prostatectomy
Adverse events of post-biopsy (pain, infection, bleeding etc.)
Inter-observer variability among radiologists

Full Information

First Posted
March 19, 2020
Last Updated
March 23, 2020
Sponsor
Asan Medical Center
Collaborators
Bumjin Lim, Dalsan Yoo, Hyung Keun Park, Jun Hyuk Hong, Hanjong Ahn, Choung-Soo Kim, Kye Jin Park, Mi-Hyun Kim, Jeong Kon Kim
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1. Study Identification

Unique Protocol Identification Number
NCT04320147
Brief Title
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer
Official Title
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2020 (Anticipated)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Bumjin Lim, Dalsan Yoo, Hyung Keun Park, Jun Hyuk Hong, Hanjong Ahn, Choung-Soo Kim, Kye Jin Park, Mi-Hyun Kim, Jeong Kon Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, MR-target Biopsy, Artemis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI tartget biopsy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Artemia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of clinically significant prostate cancer (≥Gleason score 3+4)
Time Frame
2 week after the procedure
Secondary Outcome Measure Information:
Title
Proportion of clinically insignificant prostate cancer (Gleason score 6)
Time Frame
2 week after the procedure
Title
Proportion of men in whom mpMRI score (PI-RADS) for suspicion of clinically significant cancer was 3, 4 or 5
Time Frame
2 week after the procedure
Title
Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer
Time Frame
2 week after the procedure
Title
Cancer core length of the most involved biopsy core (maximum cancer core length, mm)
Time Frame
2 week after the procedure
Title
Proportion of men who go on to definitive local treatment or systemic treatment
Time Frame
2 week after the procedure
Title
Proportion of Gleason grade upgrading in men undergoing radical prostatectomy
Time Frame
2 week after the surgery
Title
Adverse events of post-biopsy (pain, infection, bleeding etc.)
Time Frame
2 week after the procedure
Title
Inter-observer variability among radiologists
Time Frame
2 week after the procedure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
In Gab Jeong, MD, PhD
Phone
82-2-3010-5892
Email
igjeong@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Gab Jeong, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In Gab Jeong, MD
Phone
82-2-3010-5892
Email
igjeong@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
In Gab Jeong, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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