comparing pet-ct using c-11 choline and 18f-fluoromethylcholine in patients with metastatic prostate cancer

Conditions: Prostate Cancer

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.

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 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

Keywords: stage iv prostate cancer