A Pilot Study of 18F-DCFBC PET/CT in Prostate Cancer
Condition: Prostatic Neoplasms, Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02190279
Sponsor: National Cancer Institute (NCI)
Phase: Early Phase 1
- Age: minimum 18 Years maximum 99 Years
- Gender: Male
- 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.
- 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
- 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.
- 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
View trial on ClinicalTrials.gov