18F-DCFBC PET/CT in Prostate Cancer
Prostatic Neoplasms, Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring Prostate Specific Membrane Antigen, Radiolabeled PET Agent, Imaging, NaF
Eligibility Criteria
- 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
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Suspected Localized Prostate Cancer
Biochemical Recurrence
Known Metastatic Disease
Patients with known localized prostate cancer with a soft tissue lesion at least 6mm or greater.
Patients with biochemical prostate cancer relapse after definitive treatment
Patients with identifiable metastatic disease on a conventional imaging modality. If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients must have confirmation of prostate cancer prior to investigational imaging.