ID

36939

Description

Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01936883

Link

https://clinicaltrials.gov/show/NCT01936883

Keywords

Versions (1)
  1. 6/22/19 6/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer Upper Tier Intermediate Risk or High Risk NCT01936883

English

Eligibility Prostate Cancer Upper Tier Intermediate Risk or High Risk NCT01936883

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
upper tier intermediate risk with at least 2 of the following factors
Description

Intermediate Risk Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C3640764
UMLS CUI [1,2]
C0600139
1. tumor-nodes-metastases tumor stage 2b or greater
Description

Secondary malignant neoplasm of lymph node TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C3258246
2. gleason score 7
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
3. psa > 10
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
4. > 50% of the biopsies positive
Description

Biopsy Percentage Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0005558
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1514241
or high risk prostate cancer with one of the following factors
Description

High risk Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0600139
1. t3a
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
2. gleason score8-10
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
3. psa >20
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
positive prostate biopsy within 6 months (reviewed centrally)
Description

Biopsy of prostate Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0194804
UMLS CUI [1,2]
C1514241
international prostate symptom score < 16
Description

International Prostate Symptom Score

Data type

boolean

Alias
UMLS CUI [1]
C1998280
prostate volume < 60 cc
Description

Prostate volume

Data type

boolean

Alias
UMLS CUI [1]
C1441416
negative staging ct and bone scan within 3 months prior to registration
Description

TNM clinical staging Negative CT | TNM clinical staging Negative Bone scan

Data type

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C3258246
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0203668
history and physical examination within 90 days prior to registration
Description

Medical History | Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0031809
european cooperative oncology group performance status 0-1 prior to registration
Description

Performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
age >45
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient suitable for procedure under anesthesia
Description

Patient Suitable Procedure Anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0184661
UMLS CUI [1,4]
C0002903
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration
Description

Invasive cancer | Exception Skin carcinoma | Exception Disease Free of Duration

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
UMLS CUI [3,4]
C0449238
previous prostatectomy, cryotherapy or high intensity focussed ultrasound for prostate cancer
Description

Prostatectomy Prostate carcinoma | Cold Therapy Prostate carcinoma | High intensity focused ultrasound Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C0010412
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0441583
UMLS CUI [3,2]
C0600139
previous pelvic irradiation or prostate brachytherapy
Description

Radiotherapy to pelvis | Brachytherapy to prostate

Data type

boolean

Alias
UMLS CUI [1]
C1536155
UMLS CUI [2]
C0854662
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Similar models

Eligibility Prostate Cancer Upper Tier Intermediate Risk or High Risk NCT01936883

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Intermediate Risk Prostate carcinoma
Item
upper tier intermediate risk with at least 2 of the following factors
boolean
C3640764 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Secondary malignant neoplasm of lymph node TNM clinical staging
Item
1. tumor-nodes-metastases tumor stage 2b or greater
boolean
C0686619 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Gleason score
Item
2. gleason score 7
boolean
C3203027 (UMLS CUI [1])
Prostate specific antigen measurement
Item
3. psa > 10
boolean
C0201544 (UMLS CUI [1])
Biopsy Percentage Positive
Item
4. > 50% of the biopsies positive
boolean
C0005558 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
High risk Prostate carcinoma
Item
or high risk prostate cancer with one of the following factors
boolean
C0332167 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
TNM clinical staging
Item
1. t3a
boolean
C3258246 (UMLS CUI [1])
Gleason score
Item
2. gleason score8-10
boolean
C3203027 (UMLS CUI [1])
Prostate specific antigen measurement
Item
3. psa >20
boolean
C0201544 (UMLS CUI [1])
Biopsy of prostate Positive
Item
positive prostate biopsy within 6 months (reviewed centrally)
boolean
C0194804 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
International Prostate Symptom Score
Item
international prostate symptom score < 16
boolean
C1998280 (UMLS CUI [1])
Prostate volume
Item
prostate volume < 60 cc
boolean
C1441416 (UMLS CUI [1])
TNM clinical staging Negative CT | TNM clinical staging Negative Bone scan
Item
negative staging ct and bone scan within 3 months prior to registration
boolean
C3258246 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C3258246 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0203668 (UMLS CUI [2,3])
Medical History | Physical Examination
Item
history and physical examination within 90 days prior to registration
boolean
C0262926 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
Performance status
Item
european cooperative oncology group performance status 0-1 prior to registration
boolean
C1518965 (UMLS CUI [1])
Age
Item
age >45
boolean
C0001779 (UMLS CUI [1])
Patient Suitable Procedure Anesthesia
Item
patient suitable for procedure under anesthesia
boolean
C0030705 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0002903 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Invasive cancer | Exception Skin carcinoma | Exception Disease Free of Duration
Item
prior invasive malignancy (except non melanoma skin cancer) unless disease-free for at least 3 years prior to registration
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
C0449238 (UMLS CUI [3,4])
Prostatectomy Prostate carcinoma | Cold Therapy Prostate carcinoma | High intensity focused ultrasound Prostate carcinoma
Item
previous prostatectomy, cryotherapy or high intensity focussed ultrasound for prostate cancer
boolean
C0033573 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0010412 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0441583 (UMLS CUI [3,1])
C0600139 (UMLS CUI [3,2])
Radiotherapy to pelvis | Brachytherapy to prostate
Item
previous pelvic irradiation or prostate brachytherapy
boolean
C1536155 (UMLS CUI [1])
C0854662 (UMLS CUI [2])
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