A Phase 3 interventional study of [18F]PSMA-PET and MRI sequences optimized for prostate cancer examinations in Prostate Cancer, sponsored by Region Västerbotten. Recruiting at 2 sites in Sweden. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Region Västerbotten · Phase 3, Interventional, and Diagnostic
In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.
Open, non-randomized, prospective multi-center trial, with consecutive recruiting, between Skåne University hospital and Umeå University Hospital.
High-risk prostate cancer patients referred for radical prostatectomy.
One or more of the following criteria
Exclusion Criteria:
One-time pre-surgical imaging using \[18F\]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)
Drug: [18F]PSMA-PET · Device: MRI sequences optimized for prostate cancer examinations
Pre-surgical imaging using \[18F\]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.
T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital
Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions
Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology.
Time frame: Pre-surgical imaging 1-6 weeks before surgery vs. post-surgery histopathology as performed within 1-4 weeks for normal clinical work-up. Within the 5-year time frame of the study, analyses will be complemented with detailed study specific histopathology
Plan to share: Yes — Trial data that are possible to de-identify (anonymize) will be made available to other research groups through an open repository such as https://zenodo.org or equivalent. Shared data will not be directly traceable to an individual participant.
Supporting information: Study protocol
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Region Västerbotten