GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: GE-148 (18F)
Intervention description: All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; MRI; PET; GE-148 (18F)

Summary:

      Background:

      - GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers
      are interested in combining the drug with a small amount of radioactive material to allow
      prostate cancer lesions to appear more clearly on imaging scans. Researchers are also
      interested in determining whether the combination can help make cancer cells in pelvic lymph
      nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine
      individuals who are scheduled to have surgery on their prostate cancer.

      Objectives:

      - To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer cells
      in pelvic lymph nodes using positron emission tomography and magnetic resonance imaging
      scanning.

      Eligibility:

      - Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled
      to have prostate removal surgery.

      Design:

        -  Participants will be screened with a physical examination, medical history, blood tests,
           and imaging studies.

        -  Participants will have magnetic resonance imaging (MRI) and positron emission tomography
           (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and PET scans
           may be performed on the same day or on different days, depending on the schedule set by
           the study researchers.

        -  Tissue samples taken during prostate removal surgery, including prostate tissue and
           pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148
           (18F).
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Subject is male and is greater than or equal to 18 years old.

          -  Subject must be scheduled to undergo standard of care prostatectomy for presumed
             localized prostate cancer at the NIH Clinical Center.

          -  Recent (within 12 months of study entry but not within 8-12 weeks before start of
             imaging study) prostate biopsy indicating the presence of adenocarcinoma of the
             prostate gland in which at least sextant biopsies were obtained.

          -  Subjects must have a minimum of 1 positive-for-cancer biopsy core.

          -  Serum creatinine within 2 weeks prior to MR imaging less than or equal to 1.8 mg/dl
             and eGFR must be greater than 30 ml/min/1.73m(2)

          -  Chemistry parameters: AST and ALT 2 x of the upper limits of normal; total bilirubin,
             of less than or equal to 2 x the upper limits of normal or less than 3.0 mg/dl in
             patients with Gilbert's syndrome.

          -  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.

          -  The subject has a clinically acceptable medical history, physical examination and
             vital signs findings during the screening period (from within 21 days before
             administration of GE-148 (18F) Injection).

        EXCLUSION CRITERIA:

          -  Known allergy to gadolinium.

          -  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.

          -  Subjects with contraindications to MRI

               -  Subjects weighing more than 136 kg (weight limit for scanner table).

               -  Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other
                  implanted electronic devices or metal not compatible with MRI.

          -  Subjects with contraindication to endorectal coil placement

               -  Severe hemorrhoids.

               -  Surgically absent rectum.

          -  Other medical conditions deemed by the principle investigator (or associates) or
             sponsor to make the subject ineligible for protocol procedures.

          -  Subjects who have previously received radiation therapy to the pelvis.

          -  Subjects who have received androgen-deprivation therapy.

          -  The subject has received, or is scheduled to receive, another IMP from 1 month before
             to 1 week after administration of GE-148 (18F) Injection.

          -  Subjects with chronic renal failure (eGFR less than 30 ml/min/1.73m(2)).