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

October 5, 2012 updated by: Odense University Hospital

Evaluation of [18F] Fluorocholine PET/CT for Detection of Regional Lymph Node Metastases From Prostate Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Steen Walter, MD, DMSci, Professor

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The [18F] Fluorocholin PET/CT and the lymphadenectomi is done within 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark

Investigators

  • Study Chair: Steen Walter, MD, DMSci, Professor, Department of Urology, Odense University Hospital, Denmark
  • 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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (Estimate)

May 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2012

Last Update Submitted That Met QC Criteria

October 5, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROPET, Project nr. 104.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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