No registrations found.
ID
Source
Health condition
prostate cancer
Sponsors and support
Jeroen Bosch Hospital
's-Hertogenbosch
Intervention
Outcome measures
Primary outcome
Cancer detection rates
Secondary outcome
Gleason score
Background summary
Despite 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.
Study objective
We 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).
Study design
Both interventions will take place on the same day, in the same biopsy session.
Intervention
In-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)
H.P. Beerlage
Post office box 90153
Den Bosch 5200 ME
The Netherlands
073-5532407
H.Beerlage@jbz.nl
H.P. Beerlage
Post office box 90153
Den Bosch 5200 ME
The Netherlands
073-5532407
H.Beerlage@jbz.nl
Inclusion criteria
Men with clinical suspicion for prostate cancer due to PSA >4 ug/L
Age 50-70 years
Biopsy naive
Exclusion criteria
PSA >30 ug/L
Contra indications for MR
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5014 |
NTR-old | NTR5787 |
CCMO | NL51982.028.15 |
OMON | NL-OMON43620 |