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Navigo™ MR-ultrasound fusion guided biopsies


- candidate number23938
- NTR NumberNTR5787
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2016
- Secondary IDsNL51982.028.15 METC Brabant
- Public TitleNavigo™ MR-ultrasound fusion guided biopsies
- Scientific TitleMR-ultrasound fusion guided prostate biopsies compared to conventional Navigo™-based prostate biopsies in the diagnosis of prostate cancer
- ACRONYM
- hypothesisWe hypothesize that MRI guided targeted prostate biopsies are equal in finding prostate cancer as systematic biopsies, and even better at finding clinical relevant prostate cancer (>Gleason 6).
- Healt Condition(s) or Problem(s) studiedProstatic neoplasms
- Inclusion criteriaMen with clinical suspicion for prostate cancer due to PSA >4 ug/L
Age 50-70 years
Biopsy naive
- Exclusion criteriaPSA >30 ug/L
Contra indications for MR
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 26-jan-2016
- planned closingdate31-mei-2016
- Target number of participants90
- InterventionsIn-patient control study.
Patients receive both interventions:
- conventional Navigo™-based systematic biopsies (12 cores)
- in case of region of interest on mpMRI: MR-US fusion targeted biopsies (max 4 cores)
- Primary outcomeCancer detection rates
- Secondary outcomeGleason score
- TimepointsBoth interventions will take place on the same day, in the same biopsy session.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES H.P. Beerlage
- CONTACT for SCIENTIFIC QUERIES H.P. Beerlage
- Sponsor/Initiator Jeroen Bosch Hospital
- Funding
(Source(s) of Monetary or Material Support)
Astellas Research Grant
- Publications
- Brief summaryDespite limitations considering the presence, staging and aggressiveness of prostate cancer, ultrasonography (US)-guided systematic biopsies (SB) are still the 'golden standard' for the diagnosis of prostate cancer. Recently, promising results have been published for targeted prostate biopsies (TB) using magnetic resonance imaging (MRI) and ultrasonography (MRI/US)-fusion platforms. With help of image fusion we are able to navigate the ultrasound guided biopsies to the region of interest (ROI) found on MRI. This may lead to better and quicker diagnosis of prostate cancer. Furthermore there will be less delay in definitive treatment of people who are diagnosed with prostate cancer earlier. Possibly a more accurate Gleason grading can be obtained resulting in more accurate work-up and leading to a more tailored treatment advise.
- Main changes (audit trail)
- RECORD16-feb-2016 - 28-mei-2016


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