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
1500 participants
OBSERVATIONAL
2024-03-29
2033-03-31
Brief Summary
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Detailed Description
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The investigators have developed an AI-based method to detect and quantify tumours and metastases in 18F-PSMA-1007 PET-CT scans in patients with prostate cancer. The method can find tumours in the prostate and metastases in pelvic lymph nodes, distant lymph nodes and in bone, both in patients referred to the PET-CT scan for primary staging of high-risk prostate cancer for secondary staging due to recurrence.
Patients referred to clinically indicated PSMA PET-CT due to either initial staging of primary high-risk prostate cancer or due to biochemical recurrence will be eligible for inclusion. The AI-based method will automatically calculate TV, TU and number of suspected lesions and this information will be stored in a database. The values will after a 5 year follow-up period be analysed with regard to overall survival (OS) and progression-free survival (PFS).
The primary aim of the present study is to evaluate how tumour burden, measured as TV and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence). A secondary aim is to evaluate how the AI-derived measurements predict time to biochemical recurrence in a sub-cohort of patients with newly diagnosed high-risk prostate cancer. Tertiary aims are to evaluate the difference in TV and TU measured with two different segmentation methods (a threshold of 50% of SUVmax in each lesion and a threshold of SUV 4) in relation to OS and biochemical PFS. The impact of the number of automatically calculated suspected lesions will also be investigated regarding OS and biochemical PFS as well as to the difference in tumour burden measured with AI and manually.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with prostate cancer
Patients referred to clinically indicated PSMA PET-CT due to initial or secondary staging of prostate cancer
AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans
Tumour burden will be automatically calculated and stored in a database. The result of the AI-based measurements will not involve the handling of the patients
Interventions
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AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans
Tumour burden will be automatically calculated and stored in a database. The result of the AI-based measurements will not involve the handling of the patients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
120 Years
MALE
No
Sponsors
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Lund University
OTHER
Elin Tragardh
OTHER
Responsible Party
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Elin Tragardh
Professor
Locations
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Skåne University Hospital
Lund, , Sweden
Skåne university hospital
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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#2022-01302-02-PSMA
Identifier Type: -
Identifier Source: org_study_id
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