Evaluating Non-invasive Assessment of Staging with 68Ga-PSMA-PET/CT and 7T-MRI of Primary Prostate Cancer
Completed
- Conditions
- Prostate cancer1003859710018188Prostate malignancy
- Registration Number
- NL-OMON48898
- Lead Sponsor
- rologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* To assess the prediction of tumour localisation, extraprostatic extension,<br /><br>metabolism and GS of 7T-MRI for PCa, based on whole-mount histopathology<br /><br>validation after radical prostatectomy.<br /><br>* To assess the prediction of tumour aggressiveness and detection of<br /><br>metastasis, of 68Ga-PSMA-PET/CT for PCa, based on the SUVmax and SUVmean,<br /><br>compared to whole-mount histopathology validation after radical prostatectomy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To find metabolic markers to predict/mirror PCa Gleason Score, and to create<br /><br>a Gleason score prediction tool for steering individualized treatment options<br /><br>in future studies.<br /><br>* To compare radiological results from 3T-MRI with 7T-MRI for the detection of<br /><br>PCa, GS and EPE.<br /><br>* To assess the ability of 7T-MRI to diagnose extraprostatic extension, by<br /><br>evaluating a threshold value of length of capsular contact of dominant lesions<br /><br>and comparing to whole-mount histopathology validation after radical<br /><br>prostatectomy. </p><br>