ID

43598

Description

Study of Quality of Life for Prostate Proton Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00489814

Link

https://clinicaltrials.gov/show/NCT00489814

Keywords

Versions (2)
  1. 6/9/17 6/9/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00489814

English

Eligibility Prostate Cancer NCT00489814

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma with gleason scoring.
Description

Proton beam radiation therapy Local Planned | Adenocarcinoma of prostate Untreated | Biopsy | Gleason score

Data type

boolean

Alias
UMLS CUI [1,1]
C0436226
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0007112
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0005558
UMLS CUI [4]
C3203027
2. 1992 ajcc clinical stage t1-t3c on digital rectal exam.
Description

Digital Rectal Examination TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1384593
UMLS CUI [1,2]
C3258246
3. psa within 4 weeks of study entry.
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
4. zubrod performance status of 0-1 with a life expectancy of at least 10 years.
Description

Zubrod Performance Status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C3714786
UMLS CUI [2]
C0023671
5. prior hormonal therapy allowed if began no more than three months prior to registration.
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
6. patient must be able to adhere to follow-up schedule either personally or via mail or phone.
Description

Clinical Study Follow-up Adherence

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1510802
7. patient must be able to speak, read and understand english.
Description

Able to speak English Language | Able to read English Language | Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0376245
8. patient must give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. histology other than adenocarcinoma.
Description

Adenocarcinoma Histology Different

Data type

boolean

Alias
UMLS CUI [1,1]
C0001418
UMLS CUI [1,2]
C4048239
UMLS CUI [1,3]
C1705242
2. evidence of distant or nodal metastasis.
Description

Distant metastasis | Secondary malignant neoplasm of lymph node

Data type

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2]
C0686619
3. prior pelvic radiotherapy or chemotherapy.
Description

Radiotherapy to pelvis | Chemotherapy Pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0030797
4. prior or planned radical prostate surgery.
Description

Operation on prostate Radical | Operation on prostate Radical Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0194790
UMLS CUI [1,2]
C0439807
UMLS CUI [2,1]
C0194790
UMLS CUI [2,2]
C0439807
UMLS CUI [2,3]
C1301732
5. prior local therapy for prostate cancer.
Description

Local Therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C0600139
6. previous and/or concurrent malignancy unless disease free for >5 years. basal cell and non-invasive squamous cell carcinoma of the skin will not exclude patient from eligibility.
Description

Malignant Neoplasms | Disease Free of | Basal cell carcinoma | Squamous cell carcinoma of skin Non-invasive

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [3]
C0007117
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C0205303
7. history of inflammatory bowel disease (e.g. crohn's disease or ulcerative colitis).
Description

Inflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis

Data type

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
8. patients with metallic devices in the hip/pelvis (e.g. hip prostheses) that may interfere with proton dosimetry will not be eligible.
Description

Metallic device Hip Interferes with Proton Dosimetry | Metallic device Pelvis Interferes with Proton Dosimetry | Hip Prosthesis

Data type

boolean

Alias
UMLS CUI [1,1]
C3693688
UMLS CUI [1,2]
C0019552
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0729603
UMLS CUI [1,5]
C0034603
UMLS CUI [2,1]
C3693688
UMLS CUI [2,2]
C0030797
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0729603
UMLS CUI [2,5]
C0034603
UMLS CUI [3]
C0019560
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Similar models

Eligibility Prostate Cancer NCT00489814

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Proton beam radiation therapy Local Planned | Adenocarcinoma of prostate Untreated | Biopsy | Gleason score
Item
1. patients who are planned to undergo local proton radiotherapy for biopsy-proven, untreated, prostate adenocarcinoma with gleason scoring.
boolean
C0436226 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0007112 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3])
C3203027 (UMLS CUI [4])
Digital Rectal Examination TNM clinical staging
Item
2. 1992 ajcc clinical stage t1-t3c on digital rectal exam.
boolean
C1384593 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
3. psa within 4 weeks of study entry.
boolean
C0201544 (UMLS CUI [1])
Zubrod Performance Status | Life Expectancy
Item
4. zubrod performance status of 0-1 with a life expectancy of at least 10 years.
boolean
C3714786 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hormone Therapy
Item
5. prior hormonal therapy allowed if began no more than three months prior to registration.
boolean
C0279025 (UMLS CUI [1])
Clinical Study Follow-up Adherence
Item
6. patient must be able to adhere to follow-up schedule either personally or via mail or phone.
boolean
C3274571 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
Able to speak English Language | Able to read English Language | Comprehension English Language
Item
7. patient must be able to speak, read and understand english.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Informed Consent
Item
8. patient must give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adenocarcinoma Histology Different
Item
1. histology other than adenocarcinoma.
boolean
C0001418 (UMLS CUI [1,1])
C4048239 (UMLS CUI [1,2])
C1705242 (UMLS CUI [1,3])
Distant metastasis | Secondary malignant neoplasm of lymph node
Item
2. evidence of distant or nodal metastasis.
boolean
C1269798 (UMLS CUI [1])
C0686619 (UMLS CUI [2])
Radiotherapy to pelvis | Chemotherapy Pelvis
Item
3. prior pelvic radiotherapy or chemotherapy.
boolean
C1536155 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
Operation on prostate Radical | Operation on prostate Radical Planned
Item
4. prior or planned radical prostate surgery.
boolean
C0194790 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0194790 (UMLS CUI [2,1])
C0439807 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Local Therapy Prostate carcinoma
Item
5. prior local therapy for prostate cancer.
boolean
C1517925 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Malignant Neoplasms | Disease Free of | Basal cell carcinoma | Squamous cell carcinoma of skin Non-invasive
Item
6. previous and/or concurrent malignancy unless disease free for >5 years. basal cell and non-invasive squamous cell carcinoma of the skin will not exclude patient from eligibility.
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3])
C0553723 (UMLS CUI [4,1])
C0205303 (UMLS CUI [4,2])
Inflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis
Item
7. history of inflammatory bowel disease (e.g. crohn's disease or ulcerative colitis).
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
Metallic device Hip Interferes with Proton Dosimetry | Metallic device Pelvis Interferes with Proton Dosimetry | Hip Prosthesis
Item
8. patients with metallic devices in the hip/pelvis (e.g. hip prostheses) that may interfere with proton dosimetry will not be eligible.
boolean
C3693688 (UMLS CUI [1,1])
C0019552 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0729603 (UMLS CUI [1,4])
C0034603 (UMLS CUI [1,5])
C3693688 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0729603 (UMLS CUI [2,4])
C0034603 (UMLS CUI [2,5])
C0019560 (UMLS CUI [3])
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