RecruitingPhase 3NCT06565247
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
Sponsor
Region Västerbotten
Enrollment
60 participants
Start Date
Oct 14, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria9
- 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 Criteria10
- 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
Interventions
DRUG[18F]PSMA-PET
Pre-surgical imaging using \[18F\]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.
DEVICEMRI sequences optimized for prostate cancer examinations
T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06565247
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