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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Cancer Research UK
ClinicalTrials.gov Identifier:
NCT01132599
First received: May 26, 2010
Last updated: February 27, 2012
Last verified: February 2012

May 26, 2010
February 27, 2012
May 2010
June 2011   (final data collection date for primary outcome measure)
Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline [ Designated as safety issue: No ]
Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01132599 on ClinicalTrials.gov Archive Site
  • 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 [ Designated as safety issue: No ]
  • Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0 [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: No ]
  • Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0 [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer
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

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.

OBJECTIVES:

  • 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

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
  • Dietary Supplement: C-11 choline
  • Radiation: 18F-fluoromethylcholine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
June 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01132599
CDR0000674024, CRUK-CR0701-21, EUDRACT-2008-004828-23
Not Provided
Cancer Research UK
Cancer Research UK
Not Provided
Principal Investigator: Michael O'Doherty, MD St. Thomas' Hospital
Cancer Research UK
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP