ID

22715

Description

Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01578902

Link

https://clinicaltrials.gov/show/NCT01578902

Keywords

Versions (1)
  1. 6/10/17 6/10/17 -
Uploaded on

June 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01578902

English

Eligibility Prostate Cancer NCT01578902

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent signed (appendix a)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
adult men greater than 18 years of age
Description

Gender | Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001675
UMLS CUI [3]
C0001779
histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
clinical stage t1-t2b, gleason score < 6, and psa < 10 ng/ml
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
less than 50% of biopsy cores +ve for cancer
Description

Biopsy Percentage Positive Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1514241
UMLS CUI [1,4]
C0006826
less than 50% overall surface area involved with cancer
Description

Body Surface Area Percentage Involvement with Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0005902
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0006826
neoadjuvant hormone suppression therapy is allowed. however, psa, must have been performed within 2 months of starting androgen suppression therapy. if androgen suppression therapy has been started lhrh agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion & radiotherapy planning.
Description

Hormone suppression therapy Neoadjuvant | Prostate specific antigen measurement | Androgen suppression | Luteinizing Hormone-releasing Hormone Agonist | Therapeutic radiology procedure Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1535931
UMLS CUI [1,2]
C0600558
UMLS CUI [2]
C0201544
UMLS CUI [3]
C1515985
UMLS CUI [4]
C1518041
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C1301732
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior pelvic radiotherapy.
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
Description

Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
diagnosis of bleeding diathesis
Description

Bleeding tendency

Data type

boolean

Alias
UMLS CUI [1]
C1458140
presence of a hip prosthesis
Description

Hip Prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0019560
pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging device)
Description

Pelvis Measurement of girth

Data type

boolean

Alias
UMLS CUI [1,1]
C0030797
UMLS CUI [1,2]
C0203911
large prostate (> 60 cm3) on imaging
Description

Large prostate Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0426732
UMLS CUI [1,2]
C0011923
severe lower urinary tract symptoms (international prostate symptom score > 15 or nocturia > 3)
Description

Lower Urinary Tract Symptoms Severe International prostate symptom score | Nocturia

Data type

boolean

Alias
UMLS CUI [1,1]
C0574785
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1998280
UMLS CUI [2]
C0028734
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Similar models

Eligibility Prostate Cancer NCT01578902

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent signed (appendix a)
boolean
C0021430 (UMLS CUI [1])
Gender | Adult | Age
Item
adult men greater than 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Adenocarcinoma of prostate
Item
histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
boolean
C0007112 (UMLS CUI [1])
TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
clinical stage t1-t2b, gleason score < 6, and psa < 10 ng/ml
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
Biopsy Percentage Positive Malignant Neoplasms
Item
less than 50% of biopsy cores +ve for cancer
boolean
C0005558 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
Body Surface Area Percentage Involvement with Malignant Neoplasms
Item
less than 50% overall surface area involved with cancer
boolean
C0005902 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
Hormone suppression therapy Neoadjuvant | Prostate specific antigen measurement | Androgen suppression | Luteinizing Hormone-releasing Hormone Agonist | Therapeutic radiology procedure Planned
Item
neoadjuvant hormone suppression therapy is allowed. however, psa, must have been performed within 2 months of starting androgen suppression therapy. if androgen suppression therapy has been started lhrh agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion & radiotherapy planning.
boolean
C1535931 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
C1515985 (UMLS CUI [3])
C1518041 (UMLS CUI [4])
C1522449 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to pelvis
Item
prior pelvic radiotherapy.
boolean
C1536155 (UMLS CUI [1])
Anticoagulants
Item
concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
boolean
C0003280 (UMLS CUI [1])
Bleeding tendency
Item
diagnosis of bleeding diathesis
boolean
C1458140 (UMLS CUI [1])
Hip Prosthesis
Item
presence of a hip prosthesis
boolean
C0019560 (UMLS CUI [1])
Pelvis Measurement of girth
Item
pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging device)
boolean
C0030797 (UMLS CUI [1,1])
C0203911 (UMLS CUI [1,2])
Large prostate Imaging
Item
large prostate (> 60 cm3) on imaging
boolean
C0426732 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Lower Urinary Tract Symptoms Severe International prostate symptom score | Nocturia
Item
severe lower urinary tract symptoms (international prostate symptom score > 15 or nocturia > 3)
boolean
C0574785 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1998280 (UMLS CUI [1,3])
C0028734 (UMLS CUI [2])
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