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Prostate Cancer Detection Rates of Standard Transrectal Prostate Biopsy and MR-guided Fusion Transrectal Prostate Biopsy

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ClinicalTrials.gov Identifier: NCT03936296
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Erciyes University Scientific Research Projects Coordination Unit
Information provided by (Responsible Party):
Abdullah Demirtas, TC Erciyes University

Brief Summary:
Prostate cancer is the most frequent cancer in men. Today serum prostate specific antigen (PSA) level and digital rectal examination (DRE) are routinely used for screening of prostate cancer. In the case of higher PSA levels and/or abnormal DRE, 10-12 core standard transrectal prostate biopsy (STRUS-B) is preferred method.Most of the pathological T1 stage tumours are diagnosed by this method. But as the prostate volume increases, cancer detection rate of STRUS-B decreases.In the last decade multiparametric prostate magnetic resonance imaging (mpMR) has gained importance in the diagnosis of prostate cancer beside the staging. Now it is possible to biopsies from lesions which are suspicious for cancer in mpMR. Recent studies have shown that mpMR guided prostate biopsies either transrectally or perineally have better cancer detection rates comparing STRUS-B, especially in patients with history of negative previous biopsy. But its use in biopsy naive settings is not recommended.In this study it is aimed to compare cancer detection rate of MR guided MR-US fusion transrectal prostate biopsy with STRUS-B.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: mpMR guided MR-US fusion transrectal prostate biopsy Procedure: 12 core standard transrectal prostate biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To perform standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy in the 2 randomized patient group
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Prostate Cancer Detection Rates of Standard Transrectal Prostate Biopsy and Multiparametric Prostate MR Guided MR-US Fusion Transrectal Prostate Biopsy
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: fusion arm
Patients in this arm will be undertaken standard transrectal prostate biopsy and MR guided MR-US fusion prostate biopsy
Procedure: mpMR guided MR-US fusion transrectal prostate biopsy
mpMR images will be loaded to US fusion platform and registration of the will be performed. Suspicious lesions on MR which have PIRADS score 3 and above are targeted. Additional 2-4 cores biopsies will be taken them
Other Name: Fusion biopsy

Standard arm
Patients in this arm will be undertaken only standard transrectal prostate biopsy
Procedure: 12 core standard transrectal prostate biopsy
Under the guidance of transrectal ultrasonography, 12 core biopsies taken from apex, apex lateral, mid, mid lateral, base and base lateral of right and left prostate lobe
Other Name: STRUS-B




Primary Outcome Measures :
  1. cancer detection rate of MR-US fusion biopsies [ Time Frame: 15 days after biopsy ]
    percentage of prostate cancer detected by fusion biopsies

  2. clinically significant cancer detection rate of MR-US fusion biopsies [ Time Frame: 15 days after biopsy ]
    percentage of prostate cancer which is ISUP group 2 and above detected by fusion biopsies

  3. cancer detection rate of STRUS-B [ Time Frame: 15 days after biopsy ]
    percentage of prostate cancer detected by STRUS-B

  4. clinically significant cancer detection rate of STRUS-B [ Time Frame: 15 days after biopsy ]
    percentage of prostate cancer which is ISUP group 2 and above detected by STRUS-B

  5. cancer detection rate of combined method (fusion + STRUS-B ) [ Time Frame: 15 days after biopsy ]
    percentage of prostate cancer detected by combined method

  6. clinically significant cancer detection rate of combined method (fusion + STRUS-B ) [ Time Frame: 15 days after biopsy ]
    percentage of prostate cancer which is ISUP group 2 and above detected by combined method



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

PSA level 2,5-10mg/dl Approving the transrectal prostate biopsy and mpMR NO contraindication for MR: glomerular filtration rate (GFR) >60ml/dk, no claustrophobia, no prosthesis or cardiac pacemaker which is not suitable for MR no contraindication for stopping antiaggregant or antithrombotic treatment. no history of previous prostate biopsy no diagnosis of prostate cancer or other malignancies

Exclusion Criteria:

  • not approving the biopsy and MR imaging
  • having prosthesis or cardiac pace maker not suitable for MR
  • having contraindication for stopping antiaggregant or antithrombotic treatment.
  • history of previous prostate biopsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936296


Contacts
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Contact: Abdullah Demirtas, Assoc. Prof +905325094494 mesane@gmail.com
Contact: Abdullah Demirtas, Assoc Prof +905325094494 mesane@gmail.com

Locations
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Turkey
Department of Urology, Ercieys University, Faculty Of Medicine, Recruiting
Kayseri, Turkey, 38039
Contact: Abdullah Demirtas, MD    +905325094494    mesane@gmail.com   
Sponsors and Collaborators
TC Erciyes University
Erciyes University Scientific Research Projects Coordination Unit
Investigators
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Principal Investigator: Abdullah Demritas, Assoc Prof Erciyes University Faculty of Medicine
Publications of Results:

Other Publications:
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Responsible Party: Abdullah Demirtas, Md, Assoc Prof, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03936296    
Other Study ID Numbers: TSG-2016-5200
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdullah Demirtas, TC Erciyes University:
multiparametric prostate magnetic resonance imaging
MR-US fusion
MR guided prostate biopsy
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases