Prostate Cancer
Conditions
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 treatment guidance of prostate cancer.
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 radical prostatectomy.
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
Sponsors
Umeå University
Region Skane
Lund University
Region Västerbotten
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed prostate cancer planned to be treated with radical prostatectomy 2. PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer. 3. ≥4 weeks since last biopsy of the prostate 4. One or more of the following criteria 1. cT3, or high suspicion of extra prostatic growth on mpMRI 2. Gleason score ≥8 3. PSA 20-49 ng/ml 5. \>18 years 6. Given a written consent to participate in the trial
Exclusion criteria
1. Non-MR-safe implants or another contraindication to MRI or PET 2. Claustrophobia 3. Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain 4. WHO PS \>1 5. Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens) 6. TUR-P within 6 months 7. Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis. 8. 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. 9. Creatinine clearance \< 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp) 10. Tinnitus or severe hearing loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions | Pre-surgical imaging 1-6 weeks before surgery vs. post-surgery histopathology as performed within 1-4 weeks for normal clinical work-up. Within the 5-year time frame of the study, analyses will be complemented with detailed study specific histopathology | Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology. |
Countries
Sweden
Contacts
Primary ContactCamilla Thellenberg Karlsson, MD, PhD
Backup ContactTufve Nyholm, PhD
Outcome results
None listed