Clinical trial NCT00670527: [18F] Fluorocholine FCH Positron Emission Tomography (PET)/Computed Tomography (CT) for Detection of Prostate Cancer Lymph Nodes Metastases
Official title: Evaluation of [18F] Fluorocholine PET/CT for Detection of Regional Lymph Node Metastases From Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
[18F] Fluorocholine PET/CT
FCH
lymph node metastasis
staging
sensitivity
specificity
PROPET
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2008-05-01
Enrollment: 205
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of regional lymph node metastases from prostate cancer. In addition, the investigators want to evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate cancer.

Detailed description: The purpose of this prospective trail is to improve the staging of patients with prostate cancer. The investigators focus on the group of patients with a newly diagnosed prostate cancer, and specifically the ones who have an intermediate and high risk of disseminated prostate cancer.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with a biopsy confirmed prostate cancer who awaits curative treatment and have
* 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 withdraw their informed consent.
* 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.

Primary outcomes:
measure: The primary target variable "metastasizes to regional lymph nodes" (yes/no) will be used to estimate the diagnostic usefulness of FCH PET/CT in terms of sensitivity, specificity, positive and negative predictive values.
timeFrame: The [18F] Fluorocholin PET/CT and the lymphadenectomi is done within 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Urology, Odense University Hospital
Study officials:
affiliation: Department of Urology, Odense University Hospital, Denmark
name: Mads Hvid Poulsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Urology, Odense University Hospital, Denmark
name: Ulla Geertsen, MD, Head of Department
role: STUDY_CHAIR
affiliation: Department of Urology, Odense University Hospital, Denmark
name: Niels Svolgaard, MD, Senior Physician
role: STUDY_CHAIR
affiliation: Department of Urology, Odense University Hospital, Denmark
name: Steen Walter, MD, DMSci, Professor
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Kirsten Bouchelouche, MD, DMSci
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Mette Høilund-Carlsen, Head Technician
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Henrik Petersen, MD, Senior Physician
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Mattias Ögren, Radiochemist, PhD
role: STUDY_CHAIR
affiliation: Department of Nuclear Medicine, Odense University Hospital, Demnark
name: Poul F Høilund-Carlsen, MD, DMSci, Professor
role: STUDY_CHAIR
affiliation: University of Southern Denmark
name: Oke Gerke, Post-Doc, PhD
role: STUDY_CHAIR
affiliation: University of Southern Denmark
name: Werner Vach, PhD, Professor
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Birgitte Svolgaard, MD, Senior Physician
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Niels Marcussen, MD, DMSci, Professor
role: STUDY_CHAIR
References:
citation: 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.