Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer

Inclusion Criteria

• •Subjects must meet all of the following criteria to be included:
• •1. Male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate.
• •2. Subject with clinical stage T1 or T2 with Gleason score of 6 or 7 (3+4 or 4+3).
• •3. At least one (1) MRI evaluable tumor with volume of 400 mm3 or greater.
• •4. At least total of 10 mm of cancer tissue based on an MRI guided 12-core biopsy.
• •5. Recent (≤ 6 months prior to study entry) negative bone scan and computerized tomography (CT) scan of abdomen/pelvis.
• •6. Life expectancy of at least 5 years.
• •7. Subjects should have adequate bone marrow function defined as an absolute peripheral granulocyte count ≥ 1,500 and platelet count of ≥ 100,000, adequate hepatic function with a bilirubin ≤ 1.5 mg/dl and serum glutamic-pyruvic transaminase (SGPT) \< 4x the upper limits of normal, adequate renal function defined as serum creatinine ≤ 2.0 mg/dl
• •8. Subjects must have a coagulation profile (prothrombin time \[PT\], partial thromboplastin time \[PTT\]) not more than 2-times the upper limit of normal and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants within 5-days of the Ad5-SGE-REIC/Dkk-3 injections is limited to local use only (for control of central line patency).
• •9. Subject is willing to refrain from sexual activity or agrees to use a barrier contraceptive device (e.g. condom) for 8-weeks after treatment with Ad5-SGE-REIC/Dkk-3.
• •10. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.