Prostate Cancer
Conditions
Keywords
stage IV prostate cancer
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
Interventions
DIETARY_SUPPLEMENTC-11 choline
RADIATION18F-fluoromethylcholine
Sponsors
Cancer Research UK
Study design
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of a true 5% difference in lesion detection using 18F-fluoromethylcholine versus C-11 choline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed