ID

22796

Description

Phase I - Pre-Radical Prostatectomy RTVP-1 Gene Therapy for Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00403221

Link

https://clinicaltrials.gov/show/NCT00403221

Keywords

Versions (1)
  1. 6/12/17 6/12/17 -
Uploaded on

June 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00403221

English

Eligibility Prostatic Neoplasms NCT00403221

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage t1c, t2 or t3 with high grade disease (gleason's 7- 10) on initial biopsy, or psa greater than 10 ng/ml with any stage or gleason score.
Description

Adenocarcinoma of prostate | Neoplasm Metastasis regional Absent | Distant metastasis Absent | TNM clinical staging | Disease Severe Biopsy | Gleason score | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1269798
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C3258246
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205082
UMLS CUI [5,3]
C0005558
UMLS CUI [6]
C3203027
UMLS CUI [7]
C0201544
recent (equal to or less than 1 month 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
life expectancy of at least 10 years.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
appropriate surgical candidate for radical prostatectomy and a performance status of equal to or less than 2 (zubrod scale).
Description

Indication Radical prostatectomy | Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0194810
UMLS CUI [2]
C3714786
patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count equal to or greater than 1,500 and platelet count of equal to or greater than 100,000, adequate hepatic function with a bilirubin equal to or less than 1.5 mg per cent and sgpt less than 2 x the upper limits of normal, adequate renal function defined as serum creatinine equal to or less than 2.0 mg per cent.
Description

Absolute neutrophil count Peripheral blood | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C0229664
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201976
patients must have normal coagulation profile (pt, ptt) 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 | Prothrombin time | Partial Thromboplastin Time measurement | Bleeding tendency Non-iatrogenic Absent | Anticoagulants Local

Data type

boolean

Alias
UMLS CUI [1]
C0005778
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0030605
UMLS CUI [4,1]
C1458140
UMLS CUI [4,2]
C0445141
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0003280
UMLS CUI [5,2]
C0205276
patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status 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
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
patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death.
Description

Radical prostatectomy Patient Inappropriate | Comorbidity Evaluation | Cause of Death Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1261322
UMLS CUI [3,1]
C0007465
UMLS CUI [3,2]
C1261322
patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders are not eligible.
Description

Heart Diseases Uncontrolled | Liver diseases Uncontrolled | Kidney Diseases Uncontrolled | nervous system disorder Uncontrolled | Mental disorders Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0027765
UMLS CUI [4,2]
C0205318
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205318
patients who are hiv positive or have chronic hepatitis b or c infections are not eligible (because of possible immune effects of these conditions).
Description

HIV Seropositivity | Hepatitis B, Chronic | Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
patients with a history of primary or secondary immunodeficiency or patients taking immunosuppressive drugs such as corticosteroids continuously for greater than 4 months [greater than 5 mg hydrocortisone/day] are ineligible. (the experimental treatment being evaluated in this protocol depends on an intact immune system. patients who have a decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
Description

Primary immune deficiency disorder | Secondary immune deficiency disorder | Immunosuppressive Agents | Adrenal Cortex Hormones | Hydrocortisone U/day | Decreased immune responsiveness

Data type

boolean

Alias
UMLS CUI [1]
C0398686
UMLS CUI [2]
C0398795
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0001617
UMLS CUI [5,1]
C0020268
UMLS CUI [5,2]
C0456683
UMLS CUI [6]
C0863087
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Similar models

Eligibility Prostatic Neoplasms NCT00403221

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Neoplasm Metastasis regional Absent | Distant metastasis Absent | TNM clinical staging | Disease Severe Biopsy | Gleason score | Prostate specific antigen measurement
Item
histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage t1c, t2 or t3 with high grade disease (gleason's 7- 10) on initial biopsy, or psa greater than 10 ng/ml with any stage or gleason score.
boolean
C0007112 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1269798 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3258246 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0005558 (UMLS CUI [5,3])
C3203027 (UMLS CUI [6])
C0201544 (UMLS CUI [7])
Bone scan Negative | CT of abdomen Negative | CT of Pelvis Negative
Item
recent (equal to or less than 1 month 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
life expectancy of at least 10 years.
boolean
C0023671 (UMLS CUI [1])
Indication Radical prostatectomy | Zubrod Performance Status
Item
appropriate surgical candidate for radical prostatectomy and a performance status of equal to or less than 2 (zubrod scale).
boolean
C3146298 (UMLS CUI [1,1])
C0194810 (UMLS CUI [1,2])
C3714786 (UMLS CUI [2])
Absolute neutrophil count Peripheral blood | Platelet Count measurement | Serum total bilirubin measurement | Alanine aminotransferase measurement | Creatinine measurement, serum
Item
patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count equal to or greater than 1,500 and platelet count of equal to or greater than 100,000, adequate hepatic function with a bilirubin equal to or less than 1.5 mg per cent and sgpt less than 2 x the upper limits of normal, adequate renal function defined as serum creatinine equal to or less than 2.0 mg per cent.
boolean
C0948762 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Blood coagulation | Prothrombin time | Partial Thromboplastin Time measurement | Bleeding tendency Non-iatrogenic Absent | Anticoagulants Local
Item
patients must have normal coagulation profile (pt, ptt) 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
C0005778 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
C1458140 (UMLS CUI [4,1])
C0445141 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0003280 (UMLS CUI [5,1])
C0205276 (UMLS CUI [5,2])
Informed Consent
Item
patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Investigational New Drugs
Item
previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status 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
unable to tolerate transrectal ultrasound.
boolean
C0373345 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Radical prostatectomy Patient Inappropriate | Comorbidity Evaluation | Cause of Death Evaluation
Item
patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death.
boolean
C0194810 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0007465 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
Heart Diseases Uncontrolled | Liver diseases Uncontrolled | Kidney Diseases Uncontrolled | nervous system disorder Uncontrolled | Mental disorders Uncontrolled
Item
patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders are not eligible.
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
HIV Seropositivity | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
patients who are hiv positive or have chronic hepatitis b or c infections are not eligible (because of possible immune effects of these conditions).
boolean
C0019699 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Primary immune deficiency disorder | Secondary immune deficiency disorder | Immunosuppressive Agents | Adrenal Cortex Hormones | Hydrocortisone U/day | Decreased immune responsiveness
Item
patients with a history of primary or secondary immunodeficiency or patients taking immunosuppressive drugs such as corticosteroids continuously for greater than 4 months [greater than 5 mg hydrocortisone/day] are ineligible. (the experimental treatment being evaluated in this protocol depends on an intact immune system. patients who have a decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
boolean
C0398686 (UMLS CUI [1])
C0398795 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0020268 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C0863087 (UMLS CUI [6])
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