Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
C-11 choline
18F-fluoromethylcholine
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring stage IV prostate cancer
Eligibility Criteria
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
Sites / Locations
- St. Thomas' Hospital
Outcomes
Primary Outcome Measures
Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline
Secondary Outcome Measures
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
Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01132599
Brief Title
Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Research UK
4. Oversight
5. 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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IV prostate cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
C-11 choline
Intervention Type
Radiation
Intervention Name(s)
18F-fluoromethylcholine
Primary Outcome Measure Information:
Title
Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline
Secondary Outcome Measure Information:
Title
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
Title
Causality of each adverse event to C-11 choline and 18F-fluoromethylcholine and adverse event severity according to NCI CTCAE version 4.0
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael O'Doherty, MD
Organizational Affiliation
St. Thomas' Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer
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