ID

31600

Description

Phase I Targeting Dominant Intraprostatic Lesion Using MR Spectroscopy and HDR Brachytherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00807820

Link

https://clinicaltrials.gov/show/NCT00807820

Keywords

Versions (1)
  1. 9/11/18 9/11/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 11, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00807820

English

Eligibility Prostate Cancer NCT00807820

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must be a candidate for hdr prostate brachytherapy
Description

Patient Appropriate High dose rate brachytherapy Prostate

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0454270
UMLS CUI [1,4]
C0033572
patient must be able to have mr scan
Description

Ability Receive MRI scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0024485
patient must have a visible dil on mrs
Description

Lesion of prostate Predominant Visible Magnetic Resonance Spectroscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0577255
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C0205379
UMLS CUI [1,4]
C0024487
patient has signed the protocol consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
no prior pelvic or prostate radiation or chemotherapy for any reason
Description

Radiotherapy to pelvis Absent | Radiotherapy to prostate Absent | Prior Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0948317
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0332197
induction hormonal therapy beginning ≤ 120 days prior to study entry is acceptable only if there is a mri/mrs done prior to starting hormonal therapy
Description

Induction Hormone Therapy | MRI prior to Hormone Therapy | MRS prior to Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0279025
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0279025
UMLS CUI [3,1]
C0024487
UMLS CUI [3,2]
C0332152
UMLS CUI [3,3]
C0279025
prostate specific antigen prior to any (hormonal) therapy must be ≤ 20 ng/ml
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
one of the following combinations of factors:
Description

Combination Factor

Data type

boolean

Alias
UMLS CUI [1,1]
C0205195
UMLS CUI [1,2]
C1521761
clinical stage t2a-2b, gleason score 2-6 and psa ≥ 10 but ≤ 20
Description

TNM clinical staging | Gleason score | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
clinical stage t3a-t3b, gleason score 2-6 and psa ≤ 20
Description

TNM clinical staging | Gleason score | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
clinical stage t2a-t3b, gleason score 7-10 and psa ≤ 20
Description

TNM clinical staging | Gleason score | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
UMLS CUI [3]
C0201544
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with hip prosthesis
Description

Hip prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0019560
patient with pacemaker
Description

Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0030163
patient with history of radical surgery for prostate
Description

Operation on prostate Radical

Data type

boolean

Alias
UMLS CUI [1,1]
C0194790
UMLS CUI [1,2]
C0439807
patient with claustrophobia
Description

Claustrophobia

Data type

boolean

Alias
UMLS CUI [1]
C0008909
patient with metal in body not safe for mr
Description

Metal Body | At risk Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0025552
UMLS CUI [1,2]
C1268086
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0024485
stage t4 disease
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
lymph node involvement (n1)
Description

Lymph Node Involvement

Data type

boolean

Alias
UMLS CUI [1]
C0806692
evidence of distant metastases (m1)
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
previous hormonal therapy beginning > 120 days prior to registration
Description

Prior Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514460
hormonal therapy prior to mri/mrs
Description

Hormone Therapy prior to MRI | Hormone Therapy prior to MRS

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0024487
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Similar models

Eligibility Prostate Cancer NCT00807820

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient Appropriate High dose rate brachytherapy Prostate
Item
patient must be a candidate for hdr prostate brachytherapy
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0454270 (UMLS CUI [1,3])
C0033572 (UMLS CUI [1,4])
Ability Receive MRI scan
Item
patient must be able to have mr scan
boolean
C0085732 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Lesion of prostate Predominant Visible Magnetic Resonance Spectroscopy
Item
patient must have a visible dil on mrs
boolean
C0577255 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0205379 (UMLS CUI [1,3])
C0024487 (UMLS CUI [1,4])
Informed Consent
Item
patient has signed the protocol consent form
boolean
C0021430 (UMLS CUI [1])
Radiotherapy to pelvis Absent | Radiotherapy to prostate Absent | Prior Chemotherapy Absent
Item
no prior pelvic or prostate radiation or chemotherapy for any reason
boolean
C1536155 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0948317 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Induction Hormone Therapy | MRI prior to Hormone Therapy | MRS prior to Hormone Therapy
Item
induction hormonal therapy beginning ≤ 120 days prior to study entry is acceptable only if there is a mri/mrs done prior to starting hormonal therapy
boolean
C0600558 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0279025 (UMLS CUI [2,3])
C0024487 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0279025 (UMLS CUI [3,3])
Prostate specific antigen measurement
Item
prostate specific antigen prior to any (hormonal) therapy must be ≤ 20 ng/ml
boolean
C0201544 (UMLS CUI [1])
Combination Factor
Item
one of the following combinations of factors:
boolean
C0205195 (UMLS CUI [1,1])
C1521761 (UMLS CUI [1,2])
TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
clinical stage t2a-2b, gleason score 2-6 and psa ≥ 10 but ≤ 20
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
clinical stage t3a-t3b, gleason score 2-6 and psa ≤ 20
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
clinical stage t2a-t3b, gleason score 7-10 and psa ≤ 20
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hip prosthesis
Item
patient with hip prosthesis
boolean
C0019560 (UMLS CUI [1])
Artificial cardiac pacemaker
Item
patient with pacemaker
boolean
C0030163 (UMLS CUI [1])
Operation on prostate Radical
Item
patient with history of radical surgery for prostate
boolean
C0194790 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
Claustrophobia
Item
patient with claustrophobia
boolean
C0008909 (UMLS CUI [1])
Metal Body | At risk Magnetic Resonance Imaging
Item
patient with metal in body not safe for mr
boolean
C0025552 (UMLS CUI [1,1])
C1268086 (UMLS CUI [1,2])
C1444641 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Disease TNM clinical staging
Item
stage t4 disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Lymph Node Involvement
Item
lymph node involvement (n1)
boolean
C0806692 (UMLS CUI [1])
Distant metastasis
Item
evidence of distant metastases (m1)
boolean
C1269798 (UMLS CUI [1])
Prior Hormone Therapy
Item
previous hormonal therapy beginning > 120 days prior to registration
boolean
C1514460 (UMLS CUI [1])
Hormone Therapy prior to MRI | Hormone Therapy prior to MRS
Item
hormonal therapy prior to mri/mrs
boolean
C0279025 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0024487 (UMLS CUI [2,3])
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