11C-Methionine and 2-18F-Fluoro-2-Deoxy-D-Glucose PET Imaging in Patients With Progressive Prostate Cancer
positron emission tomography
+ fludeoxyglucose F 18
+ methionine C 11
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Diagnostic Study
Summary
Study start date: January 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: Measure the pharmacokinetics, whole body retention of isotope, and biodistribution of C11-methionine and FDG by PET imaging and serial sampling of blood in men with progressive prostate cancer. Explore metabolism of each PET scan by comparing the sensitivity of C11-methionine or FDG by PET scanning in androgen independent prostate cancer metastases with the sensitivity of C11-methionine or FDG in androgen dependent metastases on a site by site basis. Compare C11-methionine and FDG PET scanning to standard of care diagnostic studies which include the Tc 99m bone scan, computed tomography, and magnetic resonance imaging. Patients fast for 6 hours prior to PET imaging with the exception of liberal water intake which is encouraged. A two way catheter is placed in the urinary bladder, and continuous isotonic saline irrigation is performed throughout scan acquisition to reduce the interference in imaging lesions in the pelvic lymph nodes and adjacent pelvic bones caused by radiation excreted in urine held in the bladder. Each patient receives C11-methionine intravenously. PET imaging begins immediately after injection for approximately 60 minutes total using standard imaging procedures. Immediately following the completion of imaging after C11-methionine administration, each patient receives FDG intravenously. PET imaging begins approximately 45 minutes thereafter for approximately 60 minutes using standard imaging procedures.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.173 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Until 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Must have an at least 50% increase in PSA which is sustained for a minimum of 3 observations obtained at least 1 week apart Must have development of new lesions on bone scintigraphy or greater than 50% increase in measurable disease on CT or MRI scan Metastatic disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky greater than 60% Hematopoietic: ANC greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Not specified Renal: Not specified Cardiovascular: No clinically significant cardiac disease Pulmonary: No clinically significant pulmonary disease Other: No active infection not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan Kettering Cancer Center
New York, United StatesOpen Memorial Sloan Kettering Cancer Center in Google Maps