Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
NCT ID: NCT06565247
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2024-10-14
2031-12-31
Brief Summary
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Detailed Description
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High-risk prostate cancer patients referred for radical prostatectomy.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI
One-time pre-surgical imaging using \[18F\]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)
[18F]PSMA-PET
Pre-surgical imaging using \[18F\]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.
MRI sequences optimized for prostate cancer examinations
T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital
Interventions
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[18F]PSMA-PET
Pre-surgical imaging using \[18F\]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.
MRI sequences optimized for prostate cancer examinations
T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
MALE
No
Sponsors
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Umeå University
OTHER
Region Skane
OTHER
Lund University
OTHER
Region Västerbotten
OTHER_GOV
Responsible Party
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Principal Investigators
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Camilla Thellenberg Karlsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Västerbotten
Locations
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Region Skåne
Malmo, , Sweden
Region Västerbotten
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIV-23-04-042756
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501892-14-00
Identifier Type: CTIS
Identifier Source: secondary_id
PAMP2
Identifier Type: -
Identifier Source: org_study_id
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