Biodistribution and Pharmacokinetic Study of 18F-DCFBC Prostate Specific Membrane Antigen Based PET in Patients With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Prostate cancer is the most common cancer among men in the United States. Through early
      detection and improved local therapies a large number of men will be cured. The clinical
      needs include early detection, accurate initial staging and detection of local recurrence or
      metastases in order to permit application of the most appropriate therapy. Therapeutic
      monitoring and prognostic assessment are equally important. Imaging can play an important and
      crucial role in meeting these clinical needs.

      Positron emission tomography (PET) imaging has gained an important role in the clinical
      management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific
      membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18
      positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging
      studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer
      cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission
      tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic
      properties that will represent an advance in imaging prostate cancer. This initial phase I
      study will determine the biodistribution, pharmacokinetics, and prostate specific tumor
      uptake in patients with metastatic prostate cancer.
    

Detailed description: 
      Prostate cancer is the most common cancer among men in the United States. Through early
      detection and improved local therapies a large number of men will be cured. The clinical
      needs include early detection, accurate initial staging and detection of local recurrence or
      metastases in order to permit application of the most appropriate therapy. Therapeutic
      monitoring and prognostic assessment are equally important. Imaging can play an important and
      crucial role in meeting these clinical needs.

      Positron emission tomography (PET) imaging has gained an important role in the clinical
      management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific
      membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18
      positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging
      studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer
      cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission
      tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic
      properties that will represent an advance in imaging prostate cancer. This initial phase I
      study will determine the biodistribution, pharmacokinetics, and prostate specific tumor
      uptake in patients with metastatic prostate cancer.
    

Intervention name(s): 18F-DCFBC
Intervention type(s): Drug
Intervention description(s): A bolus of 10 mCi (370 MBq) of 18F-DCFBC will be injected once into the IV line by slow push IV push.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Patients with Advanced Prostate Cancer