Christopher J Kane, MD, University of California, San Diego
Brian J Miles, MD, FACS, Baylor College of Medicine and Methodist Hospital
Study of a Recombinant Adenovirus to Treat Localized Prostate Cancer
Localized Prostate Cancer
Phase 1/Phase 2
The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3
in subjects with localized prostate cancer.
Ages Eligible: 50 Years
Accepts Healthy Volunteers:
Key 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 is between 6 and 7 (3+4 or
3. Recent (≤ 3 months prior to study entry) negative bone scan and CT scan of
4. Life expectancy of at least 5 years.
5. 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 SGPT < 4x the upper limits of normal, adequate renal
function defined as serum creatinine ≤ 2.0 mg/dl
6. Subjects must have a coagulation profile (PT, PTT) not more than 2-times the upper
limit of normal and no history of substantial non-iatrogenic bleeding diatheses. Use
of anticoagulants is limited to local use only (for control of central line patency).
7. 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
8. Subjects must sign an informed consent indicating that they are aware of the
investigational nature of the study.
Subjects meeting any of the following criteria will be excluded:
1. Hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other
investigational study drug within the past 4 weeks.
2. Unable to tolerate transrectal ultrasound.
3. Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric
disorders, that in the opinion of the investigator put the subject at significant
risk, are not eligible.
4. Subjects who are HIV positive or have active hepatitis B or C infections are not
5. Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune
disease or subjects taking immunosuppressive drugs such as corticosteroids
continuously for > 4 months [> 5 mg hydrocortisone/day] are ineligible.
6. As a result of medical review, physical examination, the Principal Investigator (or
medically qualified nominee) considers the subject unfit for the study.
UCSD Moores Cancer Center
San Diego, California, 92093
Christopher J Kane, MD
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Information obtained from ClinicalTrials.gov, on
12/10/2013. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: