ID

36870

Description

MRI-Targed Focal Ablation of the Prostate in Men With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02303054

Link

https://clinicaltrials.gov/show/NCT02303054

Keywords

Versions (1)
  1. 6/17/19 6/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02303054

English

Eligibility Prostate Cancer NCT02303054

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject population:
Description

Study Subject

Data type

boolean

Alias
UMLS CUI [1]
C0681850
men 40-80 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosis of adenocarcinoma of the prostate, confirmed by trus biopsy
Description

Adenocarcinoma of prostate TRUS

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0373345
no prior treatment for prostate cancer
Description

Prostate carcinoma Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0332155
prostate cancer clinical stage t1c
Description

Prostate carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C3258246
psa <10 ng/ml (this will be the psa level prompting the initial prostate biopsy)
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
declined all standard treatment options
Description

Standard therapy Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C1705116
pre-enrollment biopsy parameters:
Description

Biopsy Parameters | Status pre- Enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0449381
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C1516879
minimum of 12 biopsy cores
Description

Core biopsy Quantity Minimum

Data type

boolean

Alias
UMLS CUI [1,1]
C1318309
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1524031
gleason 6 (3+3) or 7 (3+4)
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
final enrollment biopsy parameters after fusion biopsy:
Description

Biopsy Parameters | Status post Fusion Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0449381
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C3898501
12 standard biopsy cores plus targeted regions based upon mri
Description

Standard Core biopsy Quantity | Core biopsy Region Targeted | Region Targeted MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C1318309
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1318309
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
C1521840
UMLS CUI [3,1]
C0205147
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0024485
gleason 6 (3+3) or 7 (3+4)
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
no demonstrated cancer diameter >1.2 cm
Description

Tumor Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1301886
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
histology other than adenocarcinoma
Description

Histology | Exception Adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0344441
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001418
biopsy does not meet inclusion criteria
Description

Biopsy Inclusion criteria failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C0231175
history of turp (transurethral resection of prostate) or other similar procedures (tumt, tuna)
Description

Transurethral Resection of Prostate | Transurethral Microwave Thermotherapy | Transurethral Needle Ablation of Prostate

Data type

boolean

Alias
UMLS CUI [1]
C0040771
UMLS CUI [2]
C1136095
UMLS CUI [3]
C1138404
history of prior pelvic radiation
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
men who have received any hormonal manipulation (antiandrogens; lhrh agonist; 5-alpha-reductase inhibitors) within the previous 12 months
Description

Gender Hormone manipulation | Androgen Antagonists | LHRH Agonist | 5-alpha Reductase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0586971
UMLS CUI [2]
C0002842
UMLS CUI [3]
C1518041
UMLS CUI [4]
C2936788
contraindication for mp mri
Description

Medical contraindication Multiparametric Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C3898221
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Similar models

Eligibility Prostate Cancer NCT02303054

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject
Item
subject population:
boolean
C0681850 (UMLS CUI [1])
Gender | Age
Item
men 40-80 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate TRUS
Item
diagnosis of adenocarcinoma of the prostate, confirmed by trus biopsy
boolean
C0007112 (UMLS CUI [1,1])
C0373345 (UMLS CUI [1,2])
Prostate carcinoma Untreated
Item
no prior treatment for prostate cancer
boolean
C0600139 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Prostate carcinoma TNM clinical staging
Item
prostate cancer clinical stage t1c
boolean
C0600139 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
psa <10 ng/ml (this will be the psa level prompting the initial prostate biopsy)
boolean
C0201544 (UMLS CUI [1])
Standard therapy Refused
Item
declined all standard treatment options
boolean
C2936643 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Biopsy Parameters | Status pre- Enrollment
Item
pre-enrollment biopsy parameters:
boolean
C0005558 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C1516879 (UMLS CUI [2,2])
Core biopsy Quantity Minimum
Item
minimum of 12 biopsy cores
boolean
C1318309 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Gleason score
Item
gleason 6 (3+3) or 7 (3+4)
boolean
C3203027 (UMLS CUI [1])
Biopsy Parameters | Status post Fusion Biopsy
Item
final enrollment biopsy parameters after fusion biopsy:
boolean
C0005558 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C3898501 (UMLS CUI [2,2])
Standard Core biopsy Quantity | Core biopsy Region Targeted | Region Targeted MRI
Item
12 standard biopsy cores plus targeted regions based upon mri
boolean
C1442989 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1318309 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C1521840 (UMLS CUI [2,3])
C0205147 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Gleason score
Item
gleason 6 (3+3) or 7 (3+4)
boolean
C3203027 (UMLS CUI [1])
Tumor Diameter
Item
no demonstrated cancer diameter >1.2 cm
boolean
C0027651 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Histology | Exception Adenocarcinoma
Item
histology other than adenocarcinoma
boolean
C0344441 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001418 (UMLS CUI [2,2])
Biopsy Inclusion criteria failed
Item
biopsy does not meet inclusion criteria
boolean
C0005558 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Transurethral Resection of Prostate | Transurethral Microwave Thermotherapy | Transurethral Needle Ablation of Prostate
Item
history of turp (transurethral resection of prostate) or other similar procedures (tumt, tuna)
boolean
C0040771 (UMLS CUI [1])
C1136095 (UMLS CUI [2])
C1138404 (UMLS CUI [3])
Radiotherapy to pelvis
Item
history of prior pelvic radiation
boolean
C1536155 (UMLS CUI [1])
Gender Hormone manipulation | Androgen Antagonists | LHRH Agonist | 5-alpha Reductase Inhibitors
Item
men who have received any hormonal manipulation (antiandrogens; lhrh agonist; 5-alpha-reductase inhibitors) within the previous 12 months
boolean
C0079399 (UMLS CUI [1,1])
C0586971 (UMLS CUI [1,2])
C0002842 (UMLS CUI [2])
C1518041 (UMLS CUI [3])
C2936788 (UMLS CUI [4])
Medical contraindication Multiparametric Magnetic Resonance Imaging
Item
contraindication for mp mri
boolean
C1301624 (UMLS CUI [1,1])
C3898221 (UMLS CUI [1,2])
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