ID

36569

Description

Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN); ODM derived from: https://clinicaltrials.gov/show/NCT01953055

Link

https://clinicaltrials.gov/show/NCT01953055

Keywords

Versions (2)
  1. 1/17/19 1/17/19 -
  2. 5/22/19 5/22/19 -
Copyright Holder

Sunnybrook Health Sciences Centre

Uploaded on

May 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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SABR in High Risk Prostate Cancer (SATURN) NCT01953055

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
men > 18 years of age
Description

Age and Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically confirmed prostate adenocarcinoma (centrally reviewed)
Description

histologically confirmed prostate adenocarcinoma (centrally reviewed)

Data type

boolean

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0007112
high risk prostate cancer, defined as at least one of clinical stage T3 or Gleason 8-10, or PSA > 20ng/ml
Description

prostate cancer risk assessment, by clinical T stage, Gleason Score, or PSA

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0086930
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0332326
UMLS CUI [4]
C0138741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior pelvic radiotherapy
Description

prior pelvic radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1536155
anticoagulation medication (if unsafe to discontinue for gold seed insertion)
Description

anticoagulation medication (if unsafe to discontinue for gold seed insertion)

Data type

boolean

Alias
UMLS CUI [1,1]
C0003280
UMLS CUI [1,2]
C1548265
UMLS CUI [2]
C4040254
diagnosis of bleeding diathesis
Description

bleeding diathesis

Data type

boolean

Alias
UMLS CUI [1]
C0005779
large prostate (>90cm³) on imaging at time of gold seed insertion
Description

prostate size on imaging at seed insertion

Data type

boolean

Alias
UMLS CUI [1]
C1287816
UMLS CUI [2,1]
C2348792
UMLS CUI [2,2]
C4040254
no evidence of castrate resistance (defined as psa < 3ng/ml while testosterone is < 0.7nmol/l)
Description

no evidence of castrate resistance (defined by PSA and testosterone)

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C4270759
UMLS CUI [2]
C0201544
UMLS CUI [3]
C0428413
definitive regional or distant metastatic disease on staging investigations
Description

definitive regional or distant metastatic disease on staging investigations

Data type

boolean

Alias
UMLS CUI [1]
C1275402
UMLS CUI [2,1]
C0205147
UMLS CUI [2,2]
C0027627
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
informed consent obtained
boolean
C0021430 (UMLS CUI [1])
Age and Gender
Item
men > 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
histologically confirmed prostate adenocarcinoma (centrally reviewed)
Item
histologically confirmed prostate adenocarcinoma (centrally reviewed)
boolean
C0679557 (UMLS CUI [1,1])
C0007112 (UMLS CUI [1,2])
prostate cancer risk assessment, by clinical T stage, Gleason Score, or PSA
Item
high risk prostate cancer, defined as at least one of clinical stage T3 or Gleason 8-10, or PSA > 20ng/ml
boolean
C0600139 (UMLS CUI [1,1])
C0086930 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0332326 (UMLS CUI [3])
C0138741 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
prior pelvic radiotherapy
Item
prior pelvic radiotherapy
boolean
C1514463 (UMLS CUI [1,1])
C1536155 (UMLS CUI [1,2])
anticoagulation medication (if unsafe to discontinue for gold seed insertion)
Item
anticoagulation medication (if unsafe to discontinue for gold seed insertion)
boolean
C0003280 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C4040254 (UMLS CUI [2])
bleeding diathesis
Item
diagnosis of bleeding diathesis
boolean
C0005779 (UMLS CUI [1])
prostate size on imaging at seed insertion
Item
large prostate (>90cm³) on imaging at time of gold seed insertion
boolean
C1287816 (UMLS CUI [1])
C2348792 (UMLS CUI [2,1])
C4040254 (UMLS CUI [2,2])
no evidence of castrate resistance (defined by PSA and testosterone)
Item
no evidence of castrate resistance (defined as psa < 3ng/ml while testosterone is < 0.7nmol/l)
boolean
C0332197 (UMLS CUI [1,1])
C4270759 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
C0428413 (UMLS CUI [3])
definitive regional or distant metastatic disease on staging investigations
Item
definitive regional or distant metastatic disease on staging investigations
boolean
C1275402 (UMLS CUI [1])
C0205147 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
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