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Trial Title:
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
NCT ID:
NCT06565247
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[18F]PSMA-PET
Description:
Pre-surgical imaging using [18F]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v.
injection.
Arm group label:
Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI
Intervention type:
Device
Intervention name:
MRI sequences optimized for prostate cancer examinations
Description:
T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital
Arm group label:
Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed high-risk 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 2024
Completion date:
December 2031
Lead sponsor:
Agency:
Region Västerbotten
Agency class:
Other
Collaborator:
Agency:
Umeå University
Agency class:
Other
Collaborator:
Agency:
Region Skane
Agency class:
Other
Collaborator:
Agency:
Lund University
Agency class:
Other
Source:
Region Västerbotten
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06565247
