Actively Recruiting
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
Led by Region Västerbotten · Updated on 2025-03-04
60
Participants Needed
2
Research Sites
372 weeks
Total Duration
On this page
Sponsors
R
Region Västerbotten
Lead Sponsor
U
Umeå University
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate cancer planned to be treated with radical prostatectomy
- PSMA-PET/CT conducted as part of clinical management for existing prostate cancer
- At least 4 weeks since last prostate biopsy
- One or more of the following: clinical stage T3 or high suspicion of extra-prostatic growth on mpMRI, Gleason score 8 or higher, PSA 20-49 ng/ml
- Older than 18 years
- Provided written consent to participate in the trial
You will not qualify if you...
- Non-MR-safe implants or any contraindication to MRI or PET
- Claustrophobia
- Unfit for MRI or PET/MRI examination for any reason such as back pain
- WHO performance status greater than 1
- Treated with neoadjuvant or concomitant anti-testosterone therapy
- Transurethral resection of the prostate (TUR-P) within 6 months
- Metastatic disease outside the pelvis in skeleton, organs, or lymph nodes
- Previous diagnosis of other malignant disease except basal cell carcinoma of skin or tumor free for at least 10 years
- Creatinine clearance below 30 ml/min
- Tinnitus or severe hearing loss
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Region Skåne
Malmö, Sweden
Actively Recruiting
2
Region Västerbotten
Umeå, Sweden
Actively Recruiting
Research Team
C
Camilla Thellenberg Karlsson, MD, PhD
CONTACT
T
Tufve Nyholm, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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