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

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GE Healthcare
• Collaborator: National Cancer Institute (NCI)

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)).