ID

36950

Description

Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02499848

Link

https://clinicaltrials.gov/show/NCT02499848

Keywords

Versions (1)
  1. 6/23/19 6/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02499848

English

Eligibility Prostate Cancer NCT02499848

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men aged ≥40 years and life expectancy of ≥10 years.
Description

Gender | Age | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0023671
serum prostate-specific antigen (psa) ≤15 ng/ml.
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
transperineal prostate biopsy within 12 months prior to dosing, with a clinically significant lesion correlating with an mpmri visible lesion.
Description

Transperineal biopsy of prostate | Lesion Clinical Significance | Correlation Lesion Visible mp-MRI

Data type

boolean

Alias
UMLS CUI [1]
C0401642
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C1707520
UMLS CUI [3,2]
C0221198
UMLS CUI [3,3]
C0205379
UMLS CUI [3,4]
C3898221
radiological stage t1-t2 n0 mx/m0 disease.
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
a visible lesion on mpmri that is accessible to prx302 transperineal injection.
Description

Lesion Visible mp-MRI | Access PRX302 Injection transperineal

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205379
UMLS CUI [1,3]
C3898221
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C1831975
UMLS CUI [2,3]
C1828121
UMLS CUI [2,4]
C0205500
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous radiation therapy to the pelvis.
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
Description

Androgen suppression Prostate carcinoma | Antiandrogen therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1515985
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C0600139
use of a 5-alpha reductase inhibitor within the 3 months prior to dosing.
Description

5-alpha Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2936788
evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
Description

Neoplasm Metastasis Extraprostatic Bone scan | Disorder of lymph node Extraprostatic Bone scan | Neoplasm Metastasis Extraprostatic Cross-sectional imaging | Disorder of lymph node Extraprostatic Cross-sectional imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1517078
UMLS CUI [1,3]
C0203668
UMLS CUI [2,1]
C0272394
UMLS CUI [2,2]
C1517078
UMLS CUI [2,3]
C0203668
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1517078
UMLS CUI [3,3]
C3824793
UMLS CUI [4,1]
C0272394
UMLS CUI [4,2]
C1517078
UMLS CUI [4,3]
C3824793
inability to tolerate a transrectal ultrasound (trus).
Description

Transrectal ultrasound Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0373345
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
known allergy to latex or gadolinium (gd).
Description

Latex allergy | Hypersensitivity Gadolinium

Data type

boolean

Alias
UMLS CUI [1]
C0577628
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0016911
previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (hifu), cryosurgery, thermal or microwave therapy to treat cancer of the prostate.
Description

Electroporation Prostate carcinoma | Radiofrequency ablation Prostate carcinoma | High intensity focused ultrasound Prostate carcinoma | Cryosurgery Prostate carcinoma | Thermal therapy Prostate carcinoma | Microwave Therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0206691
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0850292
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0441583
UMLS CUI [3,2]
C0600139
UMLS CUI [4,1]
C0010408
UMLS CUI [4,2]
C0600139
UMLS CUI [5,1]
C0454527
UMLS CUI [5,2]
C0600139
UMLS CUI [6,1]
C0438673
UMLS CUI [6,2]
C0600139
unable to have pelvic mri scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc. likely to contribute significant artifact to images).
Description

MRI of Pelvis Receive Unable | Claustrophobia Severe | Permanent pacemaker | Metallic implant

Data type

boolean

Alias
UMLS CUI [1,1]
C0203201
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0008909
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0281945
UMLS CUI [4]
C3693688
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Similar models

Eligibility Prostate Cancer NCT02499848

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Life Expectancy
Item
men aged ≥40 years and life expectancy of ≥10 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Prostate specific antigen measurement
Item
serum prostate-specific antigen (psa) ≤15 ng/ml.
boolean
C0201544 (UMLS CUI [1])
Transperineal biopsy of prostate | Lesion Clinical Significance | Correlation Lesion Visible mp-MRI
Item
transperineal prostate biopsy within 12 months prior to dosing, with a clinically significant lesion correlating with an mpmri visible lesion.
boolean
C0401642 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1707520 (UMLS CUI [3,1])
C0221198 (UMLS CUI [3,2])
C0205379 (UMLS CUI [3,3])
C3898221 (UMLS CUI [3,4])
Disease TNM clinical staging
Item
radiological stage t1-t2 n0 mx/m0 disease.
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Lesion Visible mp-MRI | Access PRX302 Injection transperineal
Item
a visible lesion on mpmri that is accessible to prx302 transperineal injection.
boolean
C0221198 (UMLS CUI [1,1])
C0205379 (UMLS CUI [1,2])
C3898221 (UMLS CUI [1,3])
C0444454 (UMLS CUI [2,1])
C1831975 (UMLS CUI [2,2])
C1828121 (UMLS CUI [2,3])
C0205500 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to pelvis
Item
previous radiation therapy to the pelvis.
boolean
C1536155 (UMLS CUI [1])
Androgen suppression Prostate carcinoma | Antiandrogen therapy Prostate carcinoma
Item
androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
boolean
C1515985 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0279492 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
5-alpha Reductase Inhibitors
Item
use of a 5-alpha reductase inhibitor within the 3 months prior to dosing.
boolean
C2936788 (UMLS CUI [1])
Neoplasm Metastasis Extraprostatic Bone scan | Disorder of lymph node Extraprostatic Bone scan | Neoplasm Metastasis Extraprostatic Cross-sectional imaging | Disorder of lymph node Extraprostatic Cross-sectional imaging
Item
evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
boolean
C0027627 (UMLS CUI [1,1])
C1517078 (UMLS CUI [1,2])
C0203668 (UMLS CUI [1,3])
C0272394 (UMLS CUI [2,1])
C1517078 (UMLS CUI [2,2])
C0203668 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C1517078 (UMLS CUI [3,2])
C3824793 (UMLS CUI [3,3])
C0272394 (UMLS CUI [4,1])
C1517078 (UMLS CUI [4,2])
C3824793 (UMLS CUI [4,3])
Transrectal ultrasound Receive Unable
Item
inability to tolerate a transrectal ultrasound (trus).
boolean
C0373345 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Latex allergy | Hypersensitivity Gadolinium
Item
known allergy to latex or gadolinium (gd).
boolean
C0577628 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0016911 (UMLS CUI [2,2])
Electroporation Prostate carcinoma | Radiofrequency ablation Prostate carcinoma | High intensity focused ultrasound Prostate carcinoma | Cryosurgery Prostate carcinoma | Thermal therapy Prostate carcinoma | Microwave Therapy Prostate carcinoma
Item
previous electroporation, radiofrequency ablation, high-intensity focused ultrasound (hifu), cryosurgery, thermal or microwave therapy to treat cancer of the prostate.
boolean
C0206691 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0850292 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0441583 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
C0010408 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0454527 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C0438673 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
MRI of Pelvis Receive Unable | Claustrophobia Severe | Permanent pacemaker | Metallic implant
Item
unable to have pelvic mri scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc. likely to contribute significant artifact to images).
boolean
C0203201 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0281945 (UMLS CUI [3])
C3693688 (UMLS CUI [4])
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