ID

15865

Description

Feasibility Study of Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer: Cyberknife vs. VMAT; ODM derived from: https://clinicaltrials.gov/show/NCT02344667

Link

https://clinicaltrials.gov/show/NCT02344667

Keywords

Versions (1)
  1. 6/17/16 6/17/16 -
Uploaded on

June 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT02344667

English

Eligibility Prostatic Neoplasms NCT02344667

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7
Description

Biopsy of prostate | Evaluation Histologic | Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C0194804
UMLS CUI [2,1]
C0220825
UMLS CUI [2,2]
C0205462
UMLS CUI [3]
C3203027
clinical stage t1-2b (ajcc 7th edition)
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
psa ≤ 10 ng/ml. psa should not be obtained within 10 days after prostate biopsy.
Description

Prostate specific antigen measurement | Biopsy of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C0194804
ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
Description

invasive cancer | Skin carcinoma | Lymphoma | Malignant Neoplasms hematogenous

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0024299
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C1512376
evidence of distant metastases
Description

distant metastases

Data type

boolean

Alias
UMLS CUI [1]
C3258247
regional lymph node involvement
Description

Lymph Node Involvement regional

Data type

boolean

Alias
UMLS CUI [1,1]
C0806692
UMLS CUI [1,2]
C0205147
previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer. previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Description

H/O: surgery Radical | Prostatectomy | Cryosurgery | High intensity focused ultrasound Prostate carcinoma | Pelvis Therapeutic radiology procedure Previous | Brachytherapy to prostate | Male Castration

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0439807
UMLS CUI [2]
C0033573
UMLS CUI [3]
C0010408
UMLS CUI [4,1]
C0441583
UMLS CUI [4,2]
C0600139
UMLS CUI [5,1]
C0030797
UMLS CUI [5,2]
C1522449
UMLS CUI [5,3]
C0205156
UMLS CUI [6]
C0854662
UMLS CUI [7]
C0007347
previous hormonal therapy, such as lhrh agonists or lhrh antagonists, anti-androgens, estrogens, or surgical castration
Description

Prior Hormone Therapy | LHRH Agonist | LHRH antagonist | Androgen Antagonists | Estrogens | Castration

Data type

boolean

Alias
UMLS CUI [1]
C1514460
UMLS CUI [2]
C1518041
UMLS CUI [3]
C1276926
UMLS CUI [4]
C0002842
UMLS CUI [5]
C0014939
UMLS CUI [6]
C0007344
use of finasteride or dutasteride within 30 days prior to registration. psa should not be obtained prior to 30 days after stopping finasteride or dutasteride.
Description

Finasteride Use | Dutasteride Use | Prostate-Specific Antigen

Data type

boolean

Alias
UMLS CUI [1,1]
C0060389
UMLS CUI [1,2]
C1524063
UMLS CUI [2,1]
C0754659
UMLS CUI [2,2]
C1524063
UMLS CUI [3]
C0138741
previous or concurrent cytotoxic chemotherapy for prostate cancer
Description

Cytotoxic Chemotherapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0600139
age < 18
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient unable to provide study-specific informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
inability to complete the expanded prostate cancer index composite (epic) questionnaire
Description

Expanded Prostate Cancer Index Composite Questionnaire | Completion Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3810535
UMLS CUI [1,2]
C0034394
UMLS CUI [2,1]
C0205197
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Prostatic Neoplasms NCT02344667

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
histologically confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Biopsy of prostate | Evaluation Histologic | Gleason score
Item
histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7
boolean
C0194804 (UMLS CUI [1])
C0220825 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
C3203027 (UMLS CUI [3])
TNM clinical staging
Item
clinical stage t1-2b (ajcc 7th edition)
boolean
C3258246 (UMLS CUI [1])
Prostate specific antigen measurement | Biopsy of prostate
Item
psa ≤ 10 ng/ml. psa should not be obtained within 10 days after prostate biopsy.
boolean
C0201544 (UMLS CUI [1])
C0194804 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
invasive cancer | Skin carcinoma | Lymphoma | Malignant Neoplasms hematogenous
Item
prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0006826 (UMLS CUI [4,1])
C1512376 (UMLS CUI [4,2])
distant metastases
Item
evidence of distant metastases
boolean
C3258247 (UMLS CUI [1])
Lymph Node Involvement regional
Item
regional lymph node involvement
boolean
C0806692 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
H/O: surgery Radical | Prostatectomy | Cryosurgery | High intensity focused ultrasound Prostate carcinoma | Pelvis Therapeutic radiology procedure Previous | Brachytherapy to prostate | Male Castration
Item
previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer. previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
boolean
C0455610 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0033573 (UMLS CUI [2])
C0010408 (UMLS CUI [3])
C0441583 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0030797 (UMLS CUI [5,1])
C1522449 (UMLS CUI [5,2])
C0205156 (UMLS CUI [5,3])
C0854662 (UMLS CUI [6])
C0007347 (UMLS CUI [7])
Prior Hormone Therapy | LHRH Agonist | LHRH antagonist | Androgen Antagonists | Estrogens | Castration
Item
previous hormonal therapy, such as lhrh agonists or lhrh antagonists, anti-androgens, estrogens, or surgical castration
boolean
C1514460 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C1276926 (UMLS CUI [3])
C0002842 (UMLS CUI [4])
C0014939 (UMLS CUI [5])
C0007344 (UMLS CUI [6])
Finasteride Use | Dutasteride Use | Prostate-Specific Antigen
Item
use of finasteride or dutasteride within 30 days prior to registration. psa should not be obtained prior to 30 days after stopping finasteride or dutasteride.
boolean
C0060389 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0754659 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0138741 (UMLS CUI [3])
Cytotoxic Chemotherapy Prostate carcinoma
Item
previous or concurrent cytotoxic chemotherapy for prostate cancer
boolean
C0677881 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Age
Item
age < 18
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable
Item
patient unable to provide study-specific informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Expanded Prostate Cancer Index Composite Questionnaire | Completion Unable
Item
inability to complete the expanded prostate cancer index composite (epic) questionnaire
boolean
C3810535 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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