GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer
GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer
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).
Background:

 -  Accurate imaging of prostate cancer is important for developing targeted minimally
 invasive therapies

 -  GE-148 (18F) Injection is a drug product formulation known as [18F]FACBC which is a
 synthetic leucine amino acid analogue. Preliminary studies demonstrated efficacy in
 primary prostate cancer and metastatic/recurrent prostate cancers. We propose to
 evaluate GE-148 (18F) Injection as a PET radiopharmaceutical for the detection of
 prostate cancer.

 Objectives: Primary Objective:

 -  To differentiate the magnitude of uptake and retention of GE-148 (18F) Injection between
 malignant prostate tumors, non-malignant prostate pathology, and regions of normal
 prostate tissue in subjects with prostate cancer.

 -  To assess the safety of a single dose of GE-148 (18F) Injection in subjects with
 prostate cancer.

 Secondary Objectives:

 -  To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection
 with quantitative assessment of AAT expression in malignant prostate tumors,
 non-malignant prostate pathology, and regions of normal prostate tissue.

 -  To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection
 with quantitative assessment of Ki-67 expression in malignant prostate tumors,
 non-malignant prostate pathology, and regions of normal prostate tissue.

 -  To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection in
 malignant prostate tumors and their Gleason Score.

 -  To assess the ability of GE-148 (18F) Injection to detect the number of discrete
 malignant prostate tumors confirmed by histopathology.

 -  To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection
 with quantitative measurement of AAT and Ki-67 expression in pelvic lymph nodes showing
 uptake of GE-148 (18F) Injection, where available.

 -  To compare the ability of PET/CT imaging with GE-148 (18F) Injection to predict prostate
 malignancy and distinguish it from other pathologies (inflammation, hyperplasia,
 atrophy, hemorrhage) with that of T2W MRI, DCE MRI, MR DWI, and MRSI performed at 3T.

 Eligibility:

 -  Subject is 18 years old, ECOG 0-2, with documented prostate cancer (minimum 1 core).

 -  Subject must be scheduled to undergo standard of care prostatectomy at NIH CC

 Serum creatinine within 2 weeks prior to MRI less than or equal to1.8mg/dl, estimated
 GFR(eGFR) must be greater than 30 ml/min/1.73m2.

 -Chemistry parameters: Aspartate aminotransferase (AST), Alanine transferase (ALT)2 x of the
 upper limits of normal; total bilirubin, of less than 2 x the upper limits of normal or less
 than 3.0 mg/dl in patients with Gilbert's syndrome.

 Design:

 Thirty subjects with localized prostate cancer scheduled for prostatectomy will undergo
 dynamic GE-148 (18F) Injection PET/CT imaging, and undergo a standard-of-care endorectal
 coil/pelvic multiparametric MRI . Results will be compared with pathology.
-  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)).