18F-DCFBC PET/CT in Prostate Cancer
Condition: Prostatic Neoplasms; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Early Phase 1

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 a radiotracer called
      N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
      (18F-DCFBC).

      Objective:

      - To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.

      Eligibility:

      - Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have
      relapsed, or has spread outside the prostate.

      Design:

        -  Participants will be screened with physical exam and medical history. They will give a
           blood sample.

        -  Participants will be divided into three groups.

      Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or
      biopsy at National Institutes of Health (NIH).

      Group 2: people who had their prostate removed or had radiation therapy and now have a rising
      prostate-specific antigen (PSA) without other signs of disease.

      Group 3: people whose cancer has spread to other areas of the body.

        -  Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission
           tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on
           their back on the scanner table.

        -  Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the
           rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a
           contrast agent injected through an intravenous line.

        -  Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21
           days of the 18F-DCFBC scan to look for prostate cancer in the bone.

        -  Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.

        -  A few days after each scan, participants will be contacted for follow-up.
    

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 specific and new, more specific molecular imaging probes are sought.

        -  Many prostate cancers express the prostate specific membrane antigen (PSMA) a
           transmembrane protein with N-acetylated alpha-linked acidic dipeptidase (NAALADase)
           enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited
           expression in normal tissue.

        -  N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
           (18F-DCFBC) is a radiolabeled positron emission tomography (PET) agent which binds with
           high affinity to PSMA and through whole-body non-invasive functional imaging, may
           provide new information on the expression of PSMA.

      Primary Objective

      - To assess the ability of 18F-DCFBC to differentiate between tumorous and nontumorous
      tissues in localized, recurrent (based on rising prostatic-specific antigen ((PSA) post
      treatment) and metastatic prostate cancer

      Eligibility

        -  Subject is greater than or equal to 18 years old

        -  Eastern Cooperative Oncology Group (ECOG) 0-2 with adenocarcinoma of the prostate and
           fits criteria for one of the following:

        -  ARM 1

           -- Patients with known localized prostate cancer with a soft tissue lesion at least 6mm
           or greater.

           ---A multiparametric magnetic resonance imaging (MRI) (standard of care at the National
           Institutes of Health ((NIH) Clinical Center) must be performed within 4 months
           of18F-DCFBC injection with findings suggestive for prostate cancer and confirmed with
           histopathology.

        -  ARM 2

             -  Patients with biochemical prostate cancer relapse after definitive treatment

                  -  For patients status post radiation therapy for prostate cancer, a PSA increase
                     from post radiation therapy nadir

                  -  OR

                  -  For patients status post prostatectomy, any PSA >/=0.2 ng/ml

             -  Nonspecific or no evidence for disease on standard imaging modality

        -  ARM 3

             -  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 18F-DCFBC imaging.

      Design

      This is a single site 3-arm study enrolling a total of 110 evaluable patients: Arm 1 will
      include 12 patients with presumed localized prostate cancer scheduled to undergo
      prostatectomy or biopsy within 4 months of enrollment; Arm 2 will include 78 patients with
      biochemical recurrence without evidence of metastasis on conventional imaging; and Arm 3 will
      include 20 patients with known metastatic disease who may or may not be on or/scheduled to
      begin therapeutic intervention. Patients with presumed localized disease will undergo a
      standard of care, clinical multiparametric endorectal coil MRI in the National Cancer
      Institute (NCI) Molecular Imaging Clinic within 4 months of screening. Patients in Arm 3 will
      undergo 2 imaging sessions: baseline and 4-6 month follow-up. Clinical records (including
      PSA) and treatment (if any) that occurred in the imaging interval must be available. All
      patients in Arm 3 will also undergo Na18F PET/CT for evaluation of bone metastases as part of
      this protocol. In order to allow for a small number of nonevaluable patients, the accrual
      ceiling will be set at 125.
    

Intervention name(s): 18F DCFBC; Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
Other intervention name(s): Na 18F PET/CT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostate Specific Membrane Antigen; Radiolabeled PET Agent; Imaging; NaF