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

* 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)).