Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
Recruiting · NCT06565247 · Interventional (participants receive a specific treatment) · Lead sponsor: Region Västerbotten
View the official record on ClinicalTrials.gov →Interventions studied
MRI sequences optimized for prostate cancer examinations[18F]PSMA-PET
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Non-MR-safe implants or another contraindication to MRI or PET
- Claustrophobia
- Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
- WHO PS \>1
- Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)
- TUR-P within 6 months
- Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
- 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.
- Creatinine clearance \< 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)
- Tinnitus or severe hearing loss
Where it is running
2 locations listed.
- Region Skåne - Malmö, Sweden
- Region Västerbotten - Umeå, Sweden