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Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01132599
Recruitment Status : Withdrawn
First Posted : May 28, 2010
Last Update Posted : February 28, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) and computed tomography (CT) imaging, may help find and diagnose metastatic prostate cancer.

PURPOSE: This phase II trial is studying the side effects of C-11 choline and 18F-fluoromethylcholine and to see how well they work when used in PET and CT imaging in patients with metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: C-11 choline Radiation: 18F-fluoromethylcholine Phase 2

Detailed Description:


  • To compare C-11 choline to 18F-fluoromethylcholine using positron emission tomography and computed tomography imaging in their ability to detect metastatic prostate cancer.
  • To compare the best early-phase (immediate) scanning of the two agents against the late-phase (one-hour delayed) 18F-fluoromethylcholine scanning in their ability to detect metastatic prostate cancer.
  • To assess the safety of C-11 choline and 18F-fluoromethylcholine in these patients.

OUTLINE: Patients receive C-11 choline IV followed by a 10-minute dynamic positron emission tomography (PET) scan over the pelvis and then 5-minute scans at each bed position, from the pelvis to the base of the skull, (up to a maximum of 7 additional bed positions) lasting up to 45 minutes on day 1. Beginning 3 hours later, patients receive 18F-fluoromethylcholine IV followed by the same scanning protocol above lasting approximately 45 minutes. An additional 1-hour delayed PET-computed tomography (CT) scanning is then performed, which involves a 5-minute scan at each bed position from the pelvis to the base of the skull (up to a maximum of 7 bed positions) with 18F-fluoromethylcholine, lasting approximately 35 minutes. Patients then undergo treatment as per the normal standard of care following participation in this trial.

After completion of study treatment, patients are followed between 3-7 days.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Cancer Research UK Phase II Trial to Compare [11C]Choline and [18F]Choline Each Given as a Single Administration Via Intravenous Injection for Imaging Patients With Metastatic Prostate Cancer
Study Start Date : May 2010
Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline

Secondary Outcome Measures :
  1. Identification of a true 5% difference in lesion detection between the best early-phase scanning, using either the 18F-fluoromethylcholine and C-11 choline, and late-phase scanning using 18F-fluoromethylcholine
  2. Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed prostate cancer
  • At least 4 metastatic lesions identified by conventional imaging with bone scintigraphy
  • Treatment-naive disease


  • WHO performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100 x 10^9/L
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN if due to tumor)
  • Fertile patients must use two forms of effective contraception 2 weeks prior to, during, and for 6 months after completion of study therapy
  • None of the following conditions that would prevent compliance with the study protocol:

    • Diabetes
    • High levels of pain/discomfort
    • Urinary incontinence
  • No history of recent significant cardiac arrhythmia
  • No concurrent congestive heart failure or prior history of NYHA class III-IV cardiac disease
  • No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial


  • No prior radiotherapy, hormone therapy, chemotherapy, endocrine therapy, or immunotherapy for the treatment of prostate cancer
  • No major thoracic and/or abdominal surgery from which the patient has not yet recovered
  • No concurrent anticancer therapy
  • No concurrent hormone therapy
  • No concurrent participation or planning to participate in another interventional clinical trial

    • Concurrent participation in an observational trial allowed
  • No other concurrent investigational drugs
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132599

United Kingdom
St. Thomas' Hospital
London, England, United Kingdom, SE1 7EH
Sponsors and Collaborators
Cancer Research UK
Principal Investigator: Michael O'Doherty, MD St. Thomas' Hospital
More Information

Responsible Party: Cancer Research UK
ClinicalTrials.gov Identifier: NCT01132599     History of Changes
Other Study ID Numbers: CDR0000674024
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by Cancer Research UK:
stage IV prostate cancer

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