ID

22539

Description

PROFIT - Prostate Fractionated Irradiation Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00304759

Link

https://clinicaltrials.gov/show/NCT00304759

Keywords

Versions (1)
  1. 6/7/17 6/7/17 -
Uploaded on

June 7, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00304759

English

Eligibility Prostate Cancer NCT00304759

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;
Description

Prostate carcinoma | Secondary malignant neoplasm of lymph node Absent | Secondary malignant neoplasm of bone Absent | Secondary malignant neoplasm of lung Absent

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0153690
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0153676
UMLS CUI [4,2]
C0332197
2. intermediate risk prostate cancer (that is, t1-2a, gleason score <6, psa 10.1-20.0 ng/ml; t2b-c gleason <6, psa ≤ 20.0 ng/ml; t1-2, gleason 7, psa ≤ 20.0 ng/ml).
Description

Intermediate Risk Prostate carcinoma | TNM clinical staging | Gleason score | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C3640764
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C3258246
UMLS CUI [3]
C3203027
UMLS CUI [4]
C0201544
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;
Description

Prostate carcinoma Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0872146
2. previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;
Description

Therapeutic procedure Prostate carcinoma | Biopsy of prostate | Transurethral Resection

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0194804
UMLS CUI [3]
C1519630
3. patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;
Description

Hormone Therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
4. any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer;
Description

Malignant Neoplasm Untreated | Malignant Neoplasm Progressive | Recurrent tumor | Skin carcinoma | Malignant Neoplasm inactive

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205329
UMLS CUI [3]
C0521158
UMLS CUI [4]
C0699893
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0544452
5. treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;
Description

Treatment Plan Inconsistent Dose Hypofractionation Constraint

Data type

boolean

Alias
UMLS CUI [1,1]
C0599880
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C4042795
UMLS CUI [1,4]
C0443288
6. previous pelvic radiotherapy;
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
7. inflammatory bowel disease.
Description

Inflammatory Bowel Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0021390
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Similar models

Eligibility Prostate Cancer NCT00304759

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma | Secondary malignant neoplasm of lymph node Absent | Secondary malignant neoplasm of bone Absent | Secondary malignant neoplasm of lung Absent
Item
1. histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;
boolean
C0600139 (UMLS CUI [1])
C0686619 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0153690 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0153676 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Intermediate Risk Prostate carcinoma | TNM clinical staging | Gleason score | Prostate specific antigen measurement
Item
2. intermediate risk prostate cancer (that is, t1-2a, gleason score <6, psa 10.1-20.0 ng/ml; t2b-c gleason <6, psa ≤ 20.0 ng/ml; t1-2, gleason 7, psa ≤ 20.0 ng/ml).
boolean
C3640764 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C3203027 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Prostate carcinoma Disease length
Item
1. histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;
boolean
C0600139 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Therapeutic procedure Prostate carcinoma | Biopsy of prostate | Transurethral Resection
Item
2. previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0194804 (UMLS CUI [2])
C1519630 (UMLS CUI [3])
Hormone Therapy Prostate carcinoma
Item
3. patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Malignant Neoplasm Untreated | Malignant Neoplasm Progressive | Recurrent tumor | Skin carcinoma | Malignant Neoplasm inactive
Item
4. any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer;
boolean
C0006826 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0521158 (UMLS CUI [3])
C0699893 (UMLS CUI [4])
C0006826 (UMLS CUI [5,1])
C0544452 (UMLS CUI [5,2])
Treatment Plan Inconsistent Dose Hypofractionation Constraint
Item
5. treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;
boolean
C0599880 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C4042795 (UMLS CUI [1,3])
C0443288 (UMLS CUI [1,4])
Radiotherapy to pelvis
Item
6. previous pelvic radiotherapy;
boolean
C1536155 (UMLS CUI [1])
Inflammatory Bowel Diseases
Item
7. inflammatory bowel disease.
boolean
C0021390 (UMLS CUI [1])
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