Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: C-11 choline Radiation: 18F-fluoromethylcholine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
- 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 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 ]
| Enrollment: | 0 |
| Study Start Date: | May 2010 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Cancer Research UK |
| ClinicalTrials.gov Identifier: | NCT01132599 History of Changes |
| Other Study ID Numbers: | CDR0000674024, CRUK-CR0701-21, EUDRACT-2008-004828-23 |
| Study First Received: | May 26, 2010 |
| Last Updated: | February 27, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Keywords provided by Cancer Research UK:
|
stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Choline Lipotropic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Lipid Regulating Agents Nootropic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013