Comparing two imaging scans with tissue samples in prostate cancer
Tests PSMA-PET and MRI scans against tissue findings in adults with high-risk prostate cancer.
Plain-language title generated from the registry record
Registry title: Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
Key facts
- Where
- Umea, SwedenSee the site
- Phase
- Phase 3
Where in Sweden
- Region VaesterbottenUmea, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Västerbotten
- Trial code
- NCT06565247EU 2022-501892-14-00
- Record updated
- 4 March 2025
- Original description
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.Read full original descriptionShow less
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
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.
Inclusion: Histologically confirmed prostate cancer planned to be treated with radical prostatectomy; PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer; ≥4 weeks since last biopsy of the prostate; One or more of the following criteria; cT3, or high suspicion of extra prostatic growth on mpMRI; Gleason score ≥8; PSA 20-49 ng/ml; >18 years; Given a written consent to participate in the trial.
Exclusion: Non-MR-safe implants or another contraindication to MRI or PET; Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens); Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour; Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis; Creatinine clearance < 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp); Claustrophobia; Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain; WHO PS >1; TUR-P within 6 months; Tinnitus or severe hearing loss.