[18F] Fluorocholine FCH Positron Emission Tomography (PET)/Computed Tomography (CT) for Detection of Prostate Cancer Lymph Nodes Metastases (PROPET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Odense University Hospital
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00670527
First received: April 29, 2008
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: [18F] Fluorocholine PET/CT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluation of [18F] Fluorocholine PET/CT for Detection of Regional Lymph Node Metastases From Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: The [18F] Fluorocholin PET/CT and the lymphadenectomi is done within 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 205
Study Start Date: January 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: [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.

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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670527

Contacts
Contact: Mads Hvid Poulsen, MD Mads.Poulsen@ouh.regionsyddanmark.dk
Contact: Steen Walter, MD, DMSci, Professor

Locations
Denmark
Department of Urology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Mads Hvid Poulsen, MD       Mads.Poulsen@ouh.regionsyddanmark.dk   
Contact: Steen Walter         
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
Principal Investigator: Mads Hvid Poulsen, MD Department of Urology, Odense University Hospital, Denmark
Study Chair: Ulla Geertsen, MD, Head of Department Department of Urology, Odense University Hospital, Denmark
Study Chair: Niels Svolgaard, MD, Senior Physician Department of Urology, Odense University Hospital, Denmark
Study Chair: Steen Walter, MD, DMSci, Professor Department of Urology, Odense University Hospital, Denmark
Study Chair: Kirsten Bouchelouche, MD, DMSci Odense University Hospital
Study Chair: Mette Høilund-Carlsen, Head Technician Odense University Hospital
Study Chair: Henrik Petersen, MD, Senior Physician Odense University Hospital
Study Chair: Mattias Ögren, Radiochemist, PhD Odense University Hospital
Study Chair: Poul F Høilund-Carlsen, MD, DMSci, Professor Department of Nuclear Medicine, Odense University Hospital, Demnark
Study Chair: Oke Gerke, Post-Doc, PhD University of Southern Denmark
Study Chair: Werner Vach, PhD, Professor University of Southern Denmark
Study Chair: Birgitte Svolgaard, MD, Senior Physician Odense University Hospital
Study Chair: Niels Marcussen, MD, DMSci, Professor Odense University Hospital
  More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mads Hvid Poulsen, MD, Department of Urology, Odense University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00670527     History of Changes
Other Study ID Numbers: PROPET, Project nr. 104.
Study First Received: April 29, 2008
Last Updated: October 5, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Prostate cancer
[18F] Fluorocholine PET/CT
FCH
lymph node metastasis
staging
sensitivity
specificity
PROPET

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014