Novel Imaging in Staging of Primary Prostate Cancer (PROSTAGE)
High Risk Prostate Cancer
About this trial
This is an interventional diagnostic trial for High Risk Prostate Cancer focused on measuring prostate cancer, imaging of prostate cancer, staging of prostate cancer, prostate specific membrane antigen (PSMA), positron emission tomography, bone scintigraphy, whole body magnetic resonance imaging, whole body computer tomography, single photon emission tomography (SPECT)
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed PC without previous PC treatment
- High-risk PC defined with one or more of the following criteria: Gleason ≥4+3, PSA ≥20, cT≥3a
- Adequate physical status defined (by treating clinician) as capability to undergo some form of active treatment for the PC and the physical status allowing the patient to undergo all study imaging modalities
- Signed informed consent
Exclusion Criteria:
- Previous PC treatment. Short-term androgen deprivation therapy is permitted if necessary for symptomatic and/or very high-risk PC patients
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
- Claustrophobia
Sites / Locations
- Department of Urology
Arms of the Study
Arm 1
Experimental
Imaging based staging of high risk PC
Each individual study patient will be imaged for PC metastasis detection with each different imaging modalities as follows: Traditional imaging (clinical standard imaging); Whole-body contrast enhanced computer tomography Planar bone scintigraphy Novel imaging (investigational imaging); SPECT/CT (investigational imaging) 18F-PSMA-PET/CT (investigational imaging) Whole-body MRI (investigational imaging) In order to define the true nature of the findings from each different imaging modality, comparison with best valuable comparator (BvC) is made. Consensus reading of all imaging modalities and follow-up data of clinical, imaging, histopathological and laboratory results are used to define BvC.