An interventional study of MR-guided in-bore prostate biopsy and MRI/US fusion-guided prostate biopsy in Prostate Cancer, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Diagnostic
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 480 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
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 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 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.
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)
Prostate cancer detection rate
Time frame: 1 week after biopsy
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Heinrich-Heine University, Duesseldorf