Status:
RECRUITING
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
Lead Sponsor:
Region Västerbotten
Collaborating Sponsors:
Umeå University
Region Skane
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 tre...
Detailed Description
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 radi...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06565247
Start Date
October 14 2024
End Date
December 1 2031
Last Update
March 4 2025
Active Locations (2)
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1
Region Skåne
Malmo, Sweden
2
Region Västerbotten
Umeå, Sweden