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

NCT00670527 | Unknown DMC

• 1 other identifier: PROPET, Project nr. 104.
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; [18F] Fluorocholine PET/CT; FCH; lymph node metastasis; staging; sensitivity; specificity; PROPET

Outcome Measures

Primary Outcomes (1)

• 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.

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

Interventions

[18F] Fluorocholine PET/CT PROCEDURE

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

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Urology, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 22520686 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphatic Metastasis; Hypersensitivity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Mads Hvid Poulsen, MD

  Department of Urology, Odense University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Mads Hvid Poulsen, MD

CONTACT

Mads.Poulsen@ouh.regionsyddanmark.dk

Steen Walter, MD, DMSci, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 8, 2012

Record last verified: 2012-10

Locations

DK (1)