ID

21644

Description

CyberKnife Radiosurgery for Localized Prostatic Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01045148

Link

https://clinicaltrials.gov/show/NCT01045148

Keywords

  1. 4/27/17 4/27/17 -
Uploaded on

April 27, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT01045148

Eligibility Prostate Cancer NCT01045148

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed adenocarcinoma of the prostate, clinical stage t1b - t2b (ajcc 6th edition, see appendix ii), nx/n0, m0.
Description

Adenocarcinoma of prostate and tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C1300072
karnofsky performance status > 80.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
patient must be ≥ 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
gleason sum < or = 7
Description

Gleason Score

Data type

boolean

Alias
UMLS CUI [1]
C0332326
prostate-specific antigen < or = 20 ng/ml
Description

PSA measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
patients must sign a study-specific informed consent form prior to study entry.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage < t1b, t2c, t3 or t4 disease (ajcc 6th edition, see appendix ii).
Description

Tumor Stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
gleason score > 7.
Description

High gleason Score

Data type

boolean

Alias
UMLS CUI [1,1]
C0205250
UMLS CUI [1,2]
C0332326
psa > 20 ng/ml.
Description

High PSA level

Data type

boolean

Alias
UMLS CUI [1,1]
C0205250
UMLS CUI [1,2]
C0201544
lymph node involvement (n1).
Description

Lymph node involvement

Data type

boolean

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

Metastases

Data type

boolean

Alias
UMLS CUI [1]
C0027627
radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical clips or other metallic foreign bodies.
Description

Radical surgery, prior pelvic radiation, pelvic surgical clips or metallic foreign bodies

Data type

boolean

Alias
UMLS CUI [1]
C0194820
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0436276
UMLS CUI [3]
C0038917
UMLS CUI [4]
C1720389
history of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three months prior to treatment).
Description

Prior hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514460
previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
Description

Prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C2735088
major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
Description

Mental disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
metallic hip prosthesis.
Description

Metallic hip prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0019560
history of inflammatory bowel disease
Description

Inflammatory bowel disease

Data type

boolean

Alias
UMLS CUI [1]
C0021390

Similar models

Eligibility Prostate Cancer NCT01045148

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate and tumor stage
Item
histologically confirmed adenocarcinoma of the prostate, clinical stage t1b - t2b (ajcc 6th edition, see appendix ii), nx/n0, m0.
boolean
C0007112 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
Karnofsky Performance Status
Item
karnofsky performance status > 80.
boolean
C0206065 (UMLS CUI [1])
Age
Item
patient must be ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Gleason Score
Item
gleason sum < or = 7
boolean
C0332326 (UMLS CUI [1])
PSA measurement
Item
prostate-specific antigen < or = 20 ng/ml
boolean
C0201544 (UMLS CUI [1])
Informed Consent
Item
patients must sign a study-specific informed consent form prior to study entry.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor Stage
Item
stage < t1b, t2c, t3 or t4 disease (ajcc 6th edition, see appendix ii).
boolean
C1300072 (UMLS CUI [1])
High gleason Score
Item
gleason score > 7.
boolean
C0205250 (UMLS CUI [1,1])
C0332326 (UMLS CUI [1,2])
High PSA level
Item
psa > 20 ng/ml.
boolean
C0205250 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
Lymph node involvement
Item
lymph node involvement (n1).
boolean
C0806692 (UMLS CUI [1])
Metastases
Item
evidence of distant metastases (m1).
boolean
C0027627 (UMLS CUI [1])
Radical surgery, prior pelvic radiation, pelvic surgical clips or metallic foreign bodies
Item
radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical clips or other metallic foreign bodies.
boolean
C0194820 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0436276 (UMLS CUI [2,2])
C0038917 (UMLS CUI [3])
C1720389 (UMLS CUI [4])
Prior hormone therapy
Item
history of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three months prior to treatment).
boolean
C1514460 (UMLS CUI [1])
Prior malignancy
Item
previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
boolean
C2735088 (UMLS CUI [1])
Mental disorder
Item
major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
boolean
C0004936 (UMLS CUI [1])
Metallic hip prosthesis
Item
metallic hip prosthesis.
boolean
C0019560 (UMLS CUI [1])
Inflammatory bowel disease
Item
history of inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])

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