ID

36950

Beschreibung

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

Stichworte

Versionen (1)
  1. 23.06.19 23.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

23. Juni 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Prostate Cancer NCT02499848

Englisch

Eligibility Prostate Cancer NCT02499848

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Gender | Age | Life Expectancy

Datentyp

boolean

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

Prostate specific antigen measurement

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Disease TNM clinical staging

Datentyp

boolean

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

Lesion Visible mp-MRI | Access PRX302 Injection transperineal

Datentyp

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
Beschreibung

Exclusion Criteria

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

Radiotherapy to pelvis

Datentyp

boolean

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

Androgen suppression Prostate carcinoma | Antiandrogen therapy Prostate carcinoma

Datentyp

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.
Beschreibung

5-alpha Reductase Inhibitors

Datentyp

boolean

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

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

Datentyp

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).
Beschreibung

Transrectal ultrasound Receive Unable

Datentyp

boolean

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

Latex allergy | Hypersensitivity Gadolinium

Datentyp

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.
Beschreibung

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

Datentyp

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).
Beschreibung

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

Datentyp

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
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Prostate Cancer NCT02499848

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video