Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ga-68 labeled HBED-CC PSMA; Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT); Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)
Intervention description: The imaging agent (Ga-68 HBED-CC PSMA) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET/CT imaging. The one-time nominal injected dose will be 3 to 7 millicurie (mCi) containing 10 - 25 μg Ga-68 HBED-CC PSMA.; Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/CT scan includes two parts: a PET scan and a CT scan. The CT portion of the scan produces a 3-D image that shows a patient's anatomy. The PET scan demonstrates function and what's occurring on a cellular level. The PET scan is unique because it images the radiation emitted from the patient while the CT records anatomical x-rays, showing the same area from another perspective; Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Coverage for the scan will extend from the patients vertex through the mid thighs. We will use 4 minute acquisitions per bed position for PET imaging.
Intervention MeSH terms: Edetic Acid; N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid; Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are imaging patients with prostate cancer using a new PET imaging agent
      (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in
      patients with high risk disease prior to prostatectomy, patients with biochemical recurrence
      and patients with castrate resistant prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Known prostate cancer with a clinical concern for the presence of metastatic disease
             as delineated below:

               -  Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of
                  the Prostate Risk Assessment) score ≥ 5, Prostate-specific antigen (PSA) ≥ 15
                  ng/mL and/or Gleason score ≥ 4+4.

               -  Patients with biochemical recurrence after prostatectomy or radiation therapy
                  with a PSA doubling time less than 12 months.

                  i. These patients may have received androgen deprivation therapy prior to
                  imaging.

               -  Patients with castrate resistant prostate cancer with progressive disease as
                  defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27).

                  i. Patients with castrate resistant prostate cancer can be either on treatment or
                  off treatment

          2. Age > 18.

          3. Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group
             (ECOG)/World Health Organization (WHO) equivalent).

          4. Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria:

          1. Patients exceeding the weight limitations of the scanner or are not able to enter the
             bore of the PET scanner due to BMI.

          2. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis,
             etc.).

          3. Inability to complete the needed investigational due to other reasons (severe
             claustrophobia, radiation phobia, etc.).