Status:
COMPLETED
18F-DCFBC PET/CT in Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostatic Neoplasms
Prostate Cancer
Eligibility:
MALE
18-99 years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Detailed Description
Background * Prostate cancer is the second leading cause of cancer deaths in American men. * Current methods of imaging advanced prostate cancer (computed tomography ((CT) and bone scan) are non spec...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subject is greater than or equal to18 years old
- Platelet count \> 50,000/mm\^3
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
- Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.
- Categories
- ARM 1 only
- --For patients with presumed localized disease (any tumor (T), nodes 0 (N0), metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI) (standard of care at the National Institutes of Health ((NIH) Clinical Center) must be performed within 4 months of the N-\[N-\[(S)-1,3-dicarboxypropyl\]carbamoyl\]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer and a prostate lesion at least 6mm or greater. Must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging.
- ARM 2 only:
- For patients status post radiation therapy for prostate cancer, any prostatic-specific antigen (PSA) increase from post radiation therapy nadir
- OR
- For patients status post prostatectomy, a PSA \>/=0.2 ng/ml
- Nonspecific or no evidence for disease on standard imaging modality
- ARM 3 only:
- Patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality. If only soft tissue metastasis, one lesion must measure at least 6mm or greater. Patients must have confirmation of prostate cancer prior to 18FDCFBC imaging
- Note: A patient who is eligible for one arm, subsequently may cross-over into a different arm.
- EXCLUSION CRITERIA:
- 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
Exclusion
Key Trial Info
Start Date :
July 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2018
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT02190279
Start Date
July 12 2014
End Date
January 11 2018
Last Update
April 23 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892