Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation
3 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Oct 2024
Typical duration for phase_3 prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2024
CompletedFirst Posted
Study publicly available on registry
August 21, 2024
CompletedStudy Start
First participant enrolled
October 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
March 4, 2025
March 1, 2025
2.1 years
August 19, 2024
March 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of PSMA-PET and mpMRI for identification and delineation of intraprostatic lesions
Spatially defined aggressive PC lesions, or subparts of lesion, identified and defined using PSMA-PET and/or mpMRI compared to histopathology.
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
Study Arms (1)
Pre-surgical imaging of high-risk prostate cancer using [18F]PSMA-PET/mpMRI or mpMRI
EXPERIMENTALOne-time pre-surgical imaging using \[18F\]PSMA-PET/mpMRI (at Umea University Hosptial) or mpMRI (at Skåne University Hospital)
Interventions
Pre-surgical imaging using \[18F\]PSMA-PET at Umea University Hospital, 3.5 MBq/kg, i.v. injection.
T2-WI, T1-WI, DCE and DWI at Umea University Hospital and at Skåne University Hospital
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Västerbottenlead
- Umeå Universitycollaborator
- Region Skanecollaborator
- Lund Universitycollaborator
Study Sites (2)
Region Skåne
Malmo, Sweden
Region Västerbotten
Umeå, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camilla Thellenberg Karlsson, MD, PhD
Region Västerbotten
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2024
First Posted
August 21, 2024
Study Start
October 14, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2031
Last Updated
March 4, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Study protocol and anonymized data will be made available after study closure.
- Access Criteria
- Study protocol will be publicly available. Anonymized data will be accessible by request.
Trial data that are possible to de-identify (anonymize) will be made available to other research groups through an open repository such as https://zenodo.org or equivalent. Shared data will not be directly traceable to an individual participant.