18F-DCFBC PET/CT in Prostate Cancer
Completed · Early Phase 1
Conditions studied: Prostatic Neoplasms, Prostate Cancer
In brief
Background: \- Prostate cancer is the second leading cause of cancer deaths in American men. A chemical called a radiotracer helps doctors get images of this type of cancer. Researchers want to test a radiotracer called N-\[N-\[(S)-1,3-dicarboxypropyl\]carbamoyl\]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC). Objective: \- To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body. Eligibility: \- Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have relapsed, or has spread outside the prostate. Design: * Participants will be screened with physical exam and medical history. They will give a blood sample. * Participants will be divided into three groups. Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or biopsy at National Institutes of Health (NIH). Group 2: people who had their prostate removed or had radiation therapy and now have a rising prostate-specific antigen (PSA) without other signs of disease. Group 3: people whose cancer has spread to other areas of the body. * Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on their back on the scanner table. * Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a contrast agent injected through an intravenous line. * Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21 days of the 18F-DCFBC scan to look for prostate cancer in the bone. * Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans. * A few days after each scan, participants will be contacted for follow-up.
Key facts
- Study ID
- NCT02190279
- Run by
- National Cancer Institute (NCI)
- People needed
- 116
- Starts
- 2014-07-12
- Expected to finish
- 2018-01-11
- Last updated by the study team
- 2019-04-23
Who can join
Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects for whom participating would significantly delay the scheduled standard of care therapy
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures.
- Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
- Serum creatinine > 2 times the upper limit of normal
- Total bilirubin > 2 times the upper limit of normal
- Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) greater than 3 times the upper limit of normal
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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