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Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy

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ClinicalTrials.gov Identifier: NCT02220517
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Brief Summary:
The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more prostate cancers than targeted MR-guided in-bore prostate.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: MR-guided in-bore prostate biopsy Device: MRI/US fusion-guided prostate biopsy Not Applicable

Detailed Description:

In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which strategy offers the highest detection rate for prostate cancer. The hypothesis of this study is that targeted MRI-guided biopsy combined with transrectal ultrasound (TRUS)-guided biopsy may potentially detect more cancers than MRI-guided prostate biopsies alone.

Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI-guided in-bore prostate biopsy. In study arm B targeted biopsies will be performed using MRI/TRUS-fusion-guided prostate biopsy with software-registration (MRI/TRUS image fusion). Patients of study arm B undergo additional systematic 12-core TRUS-guided prostate biopsy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomized Study Comparing the Diagnostic Efficacy of MR-guided in Bore Prostate Biopsy Versus MRI/US Fusion-guided Prostate Biopsy in Men With at Least One Negative Prostate Biopsy
Study Start Date : November 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A: MR-guided in-bore prostate biopsy
Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
Device: MR-guided in-bore prostate biopsy
Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.

Experimental: B: MRI/US fusion-guided prostate biopsy
Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)
Device: MRI/US fusion-guided prostate biopsy
Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)




Primary Outcome Measures :
  1. Prostate cancer detection rate [ Time Frame: 1 week after biopsy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one prior negative prostate biopsy
  • Prostate-specific antigen (PSA) > 4 ng/ml

Exclusion Criteria:

  • Known prostate cancer
  • Contraindications against MRI
  • Contraindications against 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): NCT02220517


Locations
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Germany
University Hospital Düsseldorf
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Christian Arsov, MD Department of Urology, University of Düsseldorf
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Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02220517    
Other Study ID Numbers: 003
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Heinrich-Heine University, Duesseldorf:
MRI/US fusion-guided prostate biopsy
MR-guided in-bore prostate biopsy
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases