ID

41153

Description

Study of a Recombinant Adenovirus to Treat Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01931046

Link

https://clinicaltrials.gov/show/NCT01931046

Keywords

Versions (1)
  1. 7/2/20 7/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 2, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Localized Prostate Cancer NCT01931046

English

Eligibility Localized Prostate Cancer NCT01931046

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
key inclusion criteria:
Description

Inclusion criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
subjects must meet all of the following criteria to be included:
Description

Criteria All Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1550543
1. male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate.
Description

Gender | Age | Adenocarcinoma of prostate Localized

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0007112
UMLS CUI [3,2]
C0392752
2. subject with clinical stage t1 or t2 with gleason score is between 6 and 7 (3+4 or 4+3).
Description

TNM clinical staging | Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
3. recent (≤ 3 months prior to study entry) negative bone scan and ct scan of abdomen/pelvis.
Description

Bone scan Negative | CT of abdomen Negative | CT of Pelvis Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0203668
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0412620
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C0412628
UMLS CUI [3,2]
C1513916
4. life expectancy of at least 5 years.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2,1]
C0948762
UMLS CUI [2,2]
C0229664
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0232741
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0232804
UMLS CUI [8]
C0201976
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).
Description

Blood coagulation tests | Prothrombin time assay | Activated Partial Thromboplastin Time measurement | Bleeding tendency Absent | Anticoagulants Local

Data type

boolean

Alias
UMLS CUI [1]
C0005790
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0030605
UMLS CUI [4,1]
C1458140
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0003280
UMLS CUI [5,2]
C0205276
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.
Description

Avoidance Sexual activity | Contraception, Barrier | Condom | Status post Ad5-SGE-REIC/Dkk-3

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0036864
UMLS CUI [2]
C0004764
UMLS CUI [3]
C0677582
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C2986390
8. subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects meeting any of the following criteria will be excluded:
Description

Exclusion Criteria Any Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
1. hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational study drug within the past 4 weeks.
Description

Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0013230
2. unable to tolerate transrectal ultrasound.
Description

Transrectal ultrasound Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0681850
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0681850
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C1444641
UMLS CUI [3,4]
C0681850
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C1444641
UMLS CUI [4,4]
C0681850
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205318
UMLS CUI [5,3]
C1444641
UMLS CUI [5,4]
C0681850
4. subjects who are hiv positive or have active hepatitis b or c infections are not eligible.
Description

HIV Seropositivity | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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.
Description

Primary immune deficiency disorder | Secondary immune deficiency disorder | Autoimmune Disease | Immunosuppressive Agents | Adrenal Cortex Hormones | Hydrocortisone U/day

Data type

boolean

Alias
UMLS CUI [1]
C0398686
UMLS CUI [2]
C0398795
UMLS CUI [3]
C0004364
UMLS CUI [4]
C0021081
UMLS CUI [5]
C0001617
UMLS CUI [6,1]
C0020268
UMLS CUI [6,2]
C0456683
6. as a result of medical review, physical examination, the principal investigator (or medically qualified nominee) considers the subject unfit for the study.
Description

Study Subject Participation Status Medically unfit

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3841806
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Similar models

Eligibility Localized Prostate Cancer NCT01931046

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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