Inclusion criteria Main
Item
key inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Criteria All Fulfill
Item
subjects must meet all of the following criteria to be included:
boolean
C0243161 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Gender | Age | Adenocarcinoma of prostate Localized
Item
1. male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0007112 (UMLS CUI [3,1])
C0392752 (UMLS CUI [3,2])
TNM clinical staging | Gleason score
Item
2. subject with clinical stage t1 or t2 with gleason score is between 6 and 7 (3+4 or 4+3).
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
Bone scan Negative | CT of abdomen Negative | CT of Pelvis Negative
Item
3. recent (≤ 3 months prior to study entry) negative bone scan and ct scan of abdomen/pelvis.
boolean
C0203668 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0412620 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0412628 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
Life Expectancy
Item
4. life expectancy of at least 5 years.
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count Peripheral blood | Platelet Count measurement | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
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
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2,1])
C0229664 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0232804 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
Blood coagulation tests | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Bleeding tendency Absent | Anticoagulants Local
Item
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).
boolean
C0005790 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
C1458140 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0003280 (UMLS CUI [5,1])
C0205276 (UMLS CUI [5,2])
Avoidance Sexual activity | Contraception, Barrier | Condom | Status post Ad5-SGE-REIC/Dkk-3
Item
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 ad5-sge-reic/dkk-3.
boolean
C0870186 (UMLS CUI [1,1])
C0036864 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2])
C0677582 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C2986390 (UMLS CUI [4,2])
Informed Consent
Item
8. subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Any Fulfill
Item
subjects meeting any of the following criteria will be excluded:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs
Item
1. hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational study drug within the past 4 weeks.
boolean
C0279025 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
Transrectal ultrasound Receive Unable
Item
2. unable to tolerate transrectal ultrasound.
boolean
C0373345 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Heart Disease Uncontrolled At risk Study Subject | Liver disease Uncontrolled At risk Study Subject | Kidney Disease Uncontrolled At risk Study Subject | Nervous system disorder Uncontrolled At risk Study Subject | Mental disorders Uncontrolled At risk Study Subject
Item
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.
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
C0023895 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0681850 (UMLS CUI [2,4])
C0022658 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0681850 (UMLS CUI [3,4])
C0027765 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0681850 (UMLS CUI [4,4])
C0004936 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0681850 (UMLS CUI [5,4])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
4. subjects who are hiv positive or have active hepatitis b or c infections are not eligible.
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Primary immune deficiency disorder | Secondary immune deficiency disorder | Autoimmune Disease | Immunosuppressive Agents | Adrenal Cortex Hormones | Hydrocortisone U/day
Item
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.
boolean
C0398686 (UMLS CUI [1])
C0398795 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C0001617 (UMLS CUI [5])
C0020268 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
Study Subject Participation Status Medically unfit
Item
6. as a result of medical review, physical examination, the principal investigator (or medically qualified nominee) considers the subject unfit for the study.
boolean
C2348568 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])