To prove the diagnostic accuracy of 3T multi-modality MR imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the…
ID
Source
Brief title
Condition
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the diagnostic accuracy (area under the receiver-operating
characteristic curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR
imaging in localizing prostate cancer, by correlating:
a) focal areas of low signal intensity on T2-weighted images;
b) the extent and degree of deviating metabolite ratios derived from MRSI. This
can be the choline+creatine/citrate ratio or if possible, the choline / citrate
ratio;
c) the extent and degree of apparent diffusion coefficient reduction on DWI;
d) the extent and degree of perfusion abnormality on DCE-MRI;
with the presence or absence of cancer at (reconstructed) whole mount section
histopathology.
Hypothesis: 3-Tesla multi-modality non-ERC MR will localize prostate cancer
with an accuracy of 85%.
Secondary outcome
Proving that multi-modality MR data allows for predicting tumor grade.
The parameters from the different MR methods for a tumor focus can be
correlated to the local Gleason grade of the corresponding lesion in the
histopathological specimens.
Background summary
Prostate cancer is the most frequently diagnosed malignancy and the second most
frequent cause of cancer related death in western males. In the diagnosis of
prostate cancer digital rectal examination and especially the determination of
the blood level of prostate specific antigen (PSA) are important screening
tools. Standard sextant transrectal ultrasound (TRUS) guided biopsy of the
prostate is the most common method used to detect prostate cancer in patients
following an abnormal DRE or high serum PSA levels . Histopathological
examination of (TRUS-guided) prostate biopsies remains to be the diagnostic
gold standard.
Imaging modalities like TRUS, computed tomography and FDG-PET have proven to be
too inaccurate for adequate localization. Conventional T2-weighted MR imaging
is also not optimal in this respect. Reported accuracies range from 62 to 72%.
Accurate localization of prostate cancer within the prostate has important
clinical implications. More accurate cancer localization will lead to improved
biopsy outcome, and will be needed as a guide to optimize upcoming local
therapies such as intensity modulated radiotherapy, high-intensity focused
ultrasound, thermal therapy, cryotherapy and others.
In order to improve non-invasive detection of prostate cancer, its location,
heterogeneous extent, grade and stage, currently several new MR techniques are
being explored. These include: 1H-MR spectroscopy imaging (MRSI), dynamic
contrast-enhanced MR imaging (DCE-MRI), and diffusion weighted imaging (DWI).
MRSI provides a substantial improvement of localization compared to T2-weighted
MR imaging with accuracies between 74 and 85%. Also, the use of DCE-MRI at 1.5T
results in high localization accuracies (88 -89%). The combination of
T2-weighted MR imaging with DCE-MRI and MRSI further improves localization
accuracy to 91%. This is higher compared to all other non-MR imaging diagnostic
tools.
In this study the potential of the following MR methods in addition to
anatomical T2-weighted MRI are studied: MRSI, DCE MRI and DWI. The primary
objective of this prospective multi-centre study is to prove the diagnostic
accuracy of 3T multi-modality MR imaging (high resolution T2-weighted MRI,
DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other
prostate tissue. The gold standard for distinguishing the tissue types is the
analysis of whole-mount sections of the resected prostate by a genitourinary
histopathologist.
Study objective
To prove the diagnostic accuracy of 3T multi-modality MR imaging (high
resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing
carcinoma from other prostate tissue. The gold standard for distinguishing the
tissue types is the analysis of whole-mount sections of the resected prostate
by a genitourinary histopathologist.
Study design
Prospective multi-centre clinicopathologic study. Two-hundred patients will be
included in this study.
Study burden and risks
MR imaging may cause some discomfort, such as feelings of claustrophobia and
discomfort due to loud sounds of the MR instrument during the study. Patients
are screened for prior claustrophobic symptoms using the same screening form
described above to search for metal device and foreign bodies. Earplugs are
provided to all patients in order to minimize the discomfort related to the
loud noise.
Geert Grooteplein 10
6500HB Nijmegen
NL
Geert Grooteplein 10
6500HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
• Patients with biopsy-proven diagnosis of adenocarcinoma of the prostate
• Radical prostatectomy and histopathological exam planned
Exclusion criteria
• Patients who are unable to undergo an MR exam, including subjects with contra-indications to MR exams
• Therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostat
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL26836.091.09 |