[18F] Fluorocholine FCH Positron Emission Tomography (PET)/Computed Tomography (CT) for Detection of Prostate Cancer Lymph Nodes Metastases
NCT ID: NCT00670527
Last Updated: 2012-10-08
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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UNKNOWN
NA
205 participants
INTERVENTIONAL
2008-01-31
2013-04-30
Brief Summary
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Detailed Description
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The aim is to improve staging by replacing the traditional invasive method, the lymphadenectomy, which has a rather low sensitivity by a non-invasive method, 18F-choline PET/CT which has a presumably superior sensitivity.
The treatment of patients with prostate cancer relies on the stage of the disease. Patients with disseminated prostate cancer are incurable and are treated with palliatively. In contrast, patients with localized prostate cancer are offered curative therapy. Hence, the stage of prostate cancer is crucial for the choice of treatment.
The potential benefits are
* The patients avoid the surgical trauma including complications and convalescents period.
* The accuracy of the prostate cancer staging is improved, the potential of which is better survival.
The patients are 18F-choline PET/CT scanned prior to their lymphadenectomy, the results of the 18F-choline PET/CT are blinded for the surgeon. The endpoint of the trail is the comparison of 18F-choline PET/CT and the histopathological investigation of the regional lymph nodes of prostate.
Assuming a prevalence of metastasised prostate cancer of 20% and a true (unknown) sensitivity of FCH PET/CT of 95%, 205 patients are sufficient to show that the sensitivity of the FCH PET/CT is greater than 80% with a power of 80% at significance level 5%. The size of the confidence interval for specificity of FCH PET/CT is expected to become reasonable small. In opposition to lymphadenectomy, FCH PET/CT results may point to metastases in neighbouring regions which gives an additional benefit to FCH PET/CT justifying a test level for sensitivity of 80%."
Accordingly 205 patients will be included over 2½ years. The first patients have been included in January 2008. Interim analyses will be done after 25, 50 and 100 patients.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
TRIPLE
Interventions
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[18F] Fluorocholine PET/CT
The patients fast 6 hours before the \[18F\]Fluorocholine PET/CT scan. \[18F\]Fluorocholine will be used as tracer with a dosage of 4 MBq per kg bodyweight. PET/CT imaging will be performed after 15 and 60 after the intravenous injection of the tracer. The patient will receive 2 full body FCH PET/CT. The CT scan is with contrast.
The radiation exposure from the CT scan is 9 mSv and from the PET scan it is 3 mSv, giving a total of 12 mSv, which equals 4 times the yearly background radiation in Denmark.
Eligibility Criteria
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Inclusion Criteria
* An elevated level of prostate-specific antigen PSA\>10 ng/mL (nanogram per milliliter) or/and
* A Gleason score \> 6 or/and
* A TNM staging of T3
Exclusion Criteria
* Patients who have a bone scan indicates metastatic prostate cancer.
* Patients who have a TNM stage is T4
In the case we detect a patient having an obvious other major illness e.g. lung cancer, the patient is referred to relevant treatment. Depending on the illness the might be excluded from the study.
MALE
No
Sponsors
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University of Southern Denmark
OTHER
Odense University Hospital
OTHER
Responsible Party
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Department of Urology, Odense University Hospital, Denmark
Principal Investigators
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Mads Hvid Poulsen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Odense University Hospital, Denmark
Ulla Geertsen, MD, Head of Department
Role: STUDY_CHAIR
Department of Urology, Odense University Hospital, Denmark
Niels Svolgaard, MD, Senior Physician
Role: STUDY_CHAIR
Department of Urology, Odense University Hospital, Denmark
Steen Walter, MD, DMSci, Professor
Role: STUDY_CHAIR
Department of Urology, Odense University Hospital, Denmark
Kirsten Bouchelouche, MD, DMSci
Role: STUDY_CHAIR
Odense University Hospital
Mette Høilund-Carlsen, Head Technician
Role: STUDY_CHAIR
Odense University Hospital
Henrik Petersen, MD, Senior Physician
Role: STUDY_CHAIR
Odense University Hospital
Mattias Ögren, Radiochemist, PhD
Role: STUDY_CHAIR
Odense University Hospital
Poul F Høilund-Carlsen, MD, DMSci, Professor
Role: STUDY_CHAIR
Department of Nuclear Medicine, Odense University Hospital, Demnark
Oke Gerke, Post-Doc, PhD
Role: STUDY_CHAIR
University of Southern Denmark
Werner Vach, PhD, Professor
Role: STUDY_CHAIR
University of Southern Denmark
Birgitte Svolgaard, MD, Senior Physician
Role: STUDY_CHAIR
Odense University Hospital
Niels Marcussen, MD, DMSci, Professor
Role: STUDY_CHAIR
Odense University Hospital
Locations
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Department of Urology, Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Steen Walter, MD, DMSci, Professor
Role: CONTACT
Facility Contacts
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Mads Hvid Poulsen, MD
Role: primary
Steen Walter
Role: backup
References
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Poulsen MH, Bouchelouche K, Hoilund-Carlsen PF, Petersen H, Gerke O, Steffansen SI, Marcussen N, Svolgaard N, Vach W, Geertsen U, Walter S. [18F]fluoromethylcholine (FCH) positron emission tomography/computed tomography (PET/CT) for lymph node staging of prostate cancer: a prospective study of 210 patients. BJU Int. 2012 Dec;110(11):1666-71. doi: 10.1111/j.1464-410X.2012.11150.x. Epub 2012 Apr 23.
Other Identifiers
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PROPET, Project nr. 104.
Identifier Type: -
Identifier Source: org_study_id