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

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).

Timeline

Start

2010-07

Primary completion

2012-03

Completion

2012-03

Publications

• Background Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672.
• Background Swindle P, Eastham JA, Ohori M, Kattan MW, Wheeler T, Maru N, Slawin K, Scardino PT. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol. 2005 Sep;174(3):903-7. doi: 10.1097/01.ju.0000169475.00949.78.
• Background el-Gabry EA, Halpern EJ, Strup SE, Gomella LG. Imaging prostate cancer: current and future applications. Oncology (Williston Park). 2001 Mar;15(3):325-36; discussion 339-42.

Drugs

Indications