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Trial record 6 of 154 for:    "Choline"

Whole Body Bone Scan vs 18F-Choline PET/CT in Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mike Allan Mortensen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT02232685
First received: September 3, 2014
Last updated: October 10, 2016
Last verified: October 2016
  Purpose

Prostate cancer is currently the leading newly diagnosed cancer in the industrialized world. Treatment of prostate cancer is highly dependent on the stage of the disease. Current methods for staging are known to be inaccurate. Prior studies from our department suggest that PET/CT is useful in staging of bone metastases in patients with prostate cancer. The aim of this study is to test the usefulness of Choline PET/CT for the staging of bone metastases compared to current standard methods in patients with newly diagnosed prostate cancer.

Better initial staging will result in better treatment of the individual patient. If we are able to develop a more accurate method of staging patients with undetected metastases on current staging will be spared of the side-effects associated with current treatment - impotence, incontinence, radiation damage etc.


Condition Intervention
Prostate Cancer
Device: 18F-Choline PET/CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Whole Body Bone Scan vs 18F-Choline PET/CT, Better Detection of Bone Metastases in Prostate Cancer Patients, PROSTAGE I

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Metastases to bone (yes/no) [ Time Frame: 1 day (At the time of scan interpretation) ]

Enrollment: 143
Study Start Date: September 2014
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Choline PET/CT
18F-Choline PET/CT
Device: 18F-Choline PET/CT
18F-Choline PET/CT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed, histologically verified PCa and
  • Written consent and
  • PSA ≥ 20 ng/mL and/or
  • Gleason score > 6 and/or
  • cT-stage ≥ cT2c

Exclusion Criteria:

  • Withdrawal of consent or
  • Other active malign disease
  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: NCT02232685

Locations
Denmark
Odense University Hospiatal
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
  More Information

Responsible Party: Mike Allan Mortensen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02232685     History of Changes
Other Study ID Numbers: MAM_PROSTAGE1
Study First Received: September 3, 2014
Last Updated: October 10, 2016

Keywords provided by Odense University Hospital:
Prostate cancer
Staging
PET/CT

Additional relevant MeSH terms:
Choline
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents

ClinicalTrials.gov processed this record on May 22, 2017