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MR-target Biopsy vs. TRUS-biopsy in Men with Suspicious Prostate Cancer: A paired Cohort blinded Study

Status Approved

  • First Submitted Date

    2021/02/17

  • Registered Date

    2021/03/16

  • Last Updated Date

    2021/02/17

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005999
    Unique Protocol ID 2019-0610
    Public/Brief Title MR-target Biopsy vs. TRUS-biopsy in Men with Suspicious Prostate Cancer: A paired Cohort blinded Study
    Scientific Title MR-target Biopsy vs. TRUS-biopsy in Men with Suspicious Prostate Cancer: A paired Cohort blinded Study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT04320147
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2019-0610
    Approval Date 2020-03-24
    Institutional Review Board Name Asan Medical Center Institutional Review Board
    Institutional Review Board Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Institutional Review Board Telephone 02-3010-7166
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name In Gab Jeong
    Title Prof
    Telephone +82-2-3010-5892
    Affiliation Asan Medical Center
    Address Department of Urology, Asan Medical Center, 388-1 Pungnap2-dong, Songpa-gu, Seoul 138-736, Korea
    Contact Person for Public Queries
    Name Bumjin Lim
    Title MD
    Telephone +82-2-3010-5892
    Affiliation Asan Medical Center
    Address Department of Urology, Asan Medical Center, 388-1 Pungnap2-dong, Songpa-gu, Seoul 138-736, Korea
    Contact Person for Updating Information
    Name Bumjin Lim
    Title MD
    Telephone +82-2-3010-5892
    Affiliation Asan Medical Center
    Address Department of Urology, Asan Medical Center, 388-1 Pungnap2-dong, Songpa-gu, Seoul 138-736, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-03-27 Actual
    Target Number of Participant 300
    Primary Completion Date 2021-12-31 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Asan Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2020-03-27 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Asan Medical Center
    Organization Type Medical Institute
    Project ID 2019-0610
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Asan Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    To compare MR-target vs. standard TRUS (transrectal ultrasound)-biopsy for the diagnosis of clinically significant prostate cancer.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 300
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patients who are suspected of prostate cancer and want to undergo MR-target biopsy

    Cohort/Group Description

    Patients who are suspected of prostate cancer and want to undergo MR-target biopsy
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    Patients who are suspected of prostate cancer and want to undergo MR-target biopsy
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    •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.
    Sampling Method
    ■ McNemar Test Power Analysis
    
    Numeric Results for Two-Sided Test
    				Difference	Proportion	Odds		
    Power	N	P10	P01	(P10-P01)	Discordant	Ratio	Alpha	Beta
    0.90076	215	0.150	0.050	0.100	0.200	3.000	0.05000	0.09924
    0.90039	270	0.175	0.075	0.100	0.250	2.333	0.05000	0.09961
    0.90007	325	0.200	0.100	0.100	0.300	2.000	0.05000	0.09993
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C61)Malignant neoplasm of prostate 

    Patients suspected of prostate cancer
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    50Year~80Year

    Description

    •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)
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    1.Proportion of clinically significant prostate cancer (≥Gleason score 3+4) [ Time Frame: 2 week after the procedure ]
    Timepoint
    visit 4
    Secondary Outcome(s) 1
    Outcome
    1.Proportion of clinically insignificant prostate cancer (Gleason score 6) [ Time Frame: 2 week after the procedure ]
    Timepoint
    visit 4
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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