Primary objective is to assess the prediction of tumour localisation, extraprostatic extension, metabolism and GS of 7T-MRI for PCa, based on anatomical, functional and metabolic imaging compared to whole-mount histopathology validation after…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* To assess the prediction of tumour localisation, extraprostatic extension,
metabolism and GS of 7T-MRI for PCa, based on whole-mount histopathology
validation after radical prostatectomy.
* To assess the prediction of tumour aggressiveness and detection of
metastasis, of 68Ga-PSMA-PET/CT for PCa, based on the SUVmax and SUVmean,
compared to whole-mount histopathology validation after radical prostatectomy.
Secondary outcome
* To find metabolic markers to predict/mirror PCa Gleason Score, and to create
a Gleason score prediction tool for steering individualized treatment options
in future studies.
* To compare radiological results from 3T-MRI with 7T-MRI for the detection of
PCa, GS and EPE.
* To assess the ability of 7T-MRI to diagnose extraprostatic extension, by
evaluating a threshold value of length of capsular contact of dominant lesions
and comparing to whole-mount histopathology validation after radical
prostatectomy.
Background summary
Prostate cancer (PCa) is the fifth most common cancer worldwide. If the tumour
is confined to the prostate, patients with high risk localized prostate cancer
can be treated with radical prostatectomy (RP). However, patients with
extra-prostatic extension (EPE) have an increased risk of positive surgical
margins, biochemical recurrence, and metastatic disease. The diagnostic
accuracy of MRI for local PCa staging has a high specificity but poor and
heterogeneous sensitivity (91% and 57%, respectively). In addition, PCa Gleason
score (GS) correlates with tumour aggressiveness, but prostate biopsies can
understage the tumour in up to 25-54% of cases due to sampling errors. An
improvement in accurate non-invasive assessment of tumour aggressiveness, next
to an accurate staging of PCa, is essential for an optimal and adequate
treatment plan. Using ultra-high field MRI (i.e. 7-Tesla (7T)-MRI),
extra-capsular extension could be evaluated with increased accuracy, as even
higher spatial resolutions can be achieved, therefore increasing the
sensitivity and EPE detection. In addition, the use of 68Ga-PSMA
(Galium-68-Prostate Specific Membrane Antigen) PET/CT (Positron-Emission
Tomography) allows to detect metastatic disease with high sensitivity.
Study objective
Primary objective is to assess the prediction of tumour localisation,
extraprostatic extension, metabolism and GS of 7T-MRI for PCa, based on
anatomical, functional and metabolic imaging compared to whole-mount
histopathology validation after radical prostatectomy. In addition, to assess
the prediction of tumour aggressiveness and detection of metastasis, of
68Ga-PSMA-PET/CT for PCa, based on the SUVmax and SUVmean, compared to
whole-mount histopathology validation after radical prostatectomy.
Study design
Prospective imaging (MRI & PET/CT) study.
Study burden and risks
There are no patient specific risks or benefits by participating in this study,
however this study is a required step in improving non-invasive assessment of
prostate cancer to distinguish between patients who will be accurately treated
by radical prostatectomy and those who will not.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Signed written informed consent
- Patients with clinically intermediate to high-risk localized PCa, who are planned for radical prostatectomy (i.e. Gleason score *3+4<=7).
Exclusion criteria
- Patients who are unwilling or unable to sign written informed consent
- Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the UMC Utrecht (see Appendix I for the 7T-MRI questionnaire).
- Patients with previous treatment for PCa.
- Patients with a history of radiotherapy to the pelvis.
- Patients who underwent a transurethral resection of the prostate (TURP) or stenting of the prostate
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 |
|---|---|
| CCMO | NL63273.041.18 |