The main purpose of this study is to assess whether MRI-targeted biopsy can detect a similar amount of cancer as 10-12-core TRUS biopsy.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Prostaatkanker detectie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of men with clinically significant cancer detected
Secondary outcome
Proportion of men in MRI arm who avoid biopsy
Proportion of men in whom MRI score for suspicion of clinically significant
cancer was 3, 4 or 5 but no clinically significant cancer was detected
Proportion of men who go on to definitive local treatment (e.g. radical
prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone
therapy, chemotherapy)
Proportion Gleason grade upgrading in men undergoing radical prostatectomy
Post-biopsy complications
Health-realted quality of life
Background summary
The standard way of diagnosing prostate cancer is to carry out a trans-rectal
ultrasound guided (TRUS) biopsy. This involves inserting an ultrasound probe
into the back passage after which 10-12 pieces of tissue are taken from the
prostate from areas in the prostate most likely to contain cancer. Another way
of doing a biopsy is to perform an MRI scan of the prostate on an earlier day
and use that information to help take the biopsies. If there is a suspicious
area in the prostate on the MRI, a few biopsies can be directed at where the
suspicious area is thought to be, also using a probe in the back passage. Up to
12 pieces of tissue can be taken. If there is no suspicious area on the MRI,
which occurs in about 30% of men, then no biopsy will be taken at all.
We currently do not know for certain whether using MRI directed biopsies will
allow us to detect the same, more or less prostate cancer than if we do not use
MRI. Current evidence supports the idea that using MRI directed biopsies may
detect a similar amount of cancer to when it is not used but one advantage is
it may allow a man to avoid a biopsy.
Study objective
The main purpose of this study is to assess whether MRI-targeted biopsy can
detect a similar amount of cancer as 10-12-core TRUS biopsy.
Study design
randomised study
Intervention
MRI-guided biopsy
Study burden and risks
Patiënt are required to fill out 3 questionnaires. Also, there is a chance that
MR-targeted biopsy does not detect as many cancer as 10-12 core systematic TRUS
biopsy. So these patiënt will not be treated while they should be treated.
However, current evidence supports the idea that using MRI directed biopsies
may detect a similar amount of cancer to when it is not used but one advantage
is it may allow a man to avoid a biopsy.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Men at least 18 years of age regerred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy.
PSA * 20ng/ml within the previous 3 months
Suspected stage * T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
Exclusion criteria
Prior prostate biopsy
Prior treatment for prostate cancer
Contrainidaction to MRI
Contraindication to prostate biopsy
evidence of untreated urinary tract infection
Previous hipreplacement surgery, metallic hip replacement
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02380027 |
| CCMO | NL54630.091.15 |