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

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: Male

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

View trial on ClinicalTrials.gov