ID

34005

Description

Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02192788

Link

https://clinicaltrials.gov/show/NCT02192788

Keywords

Versions (1)
  1. 1/10/19 1/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Oligometastatic Prostate Cancer NCT02192788

English

Eligibility Oligometastatic Prostate Cancer NCT02192788

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed prostate cancer, who are currently being oligometastases / oligorrecurrencia after primary treatment for their disease.
Description

Prostate carcinoma | Neoplasm Metastasis Few Post Primary treatment | Recurrence Few Post Primary treatment

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205388
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C1708063
UMLS CUI [3,1]
C0034897
UMLS CUI [3,2]
C0205388
UMLS CUI [3,3]
C0687676
UMLS CUI [3,4]
C1708063
aged ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
time to biochemical recurrence more than 1 year
Description

Time Interval Recurrence Biochemical

Data type

boolean

Alias
UMLS CUI [1,1]
C0872291
UMLS CUI [1,2]
C0034897
UMLS CUI [1,3]
C0205474
psa doubling time> 3 months
Description

Prostate-Specific Antigen Doubling Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C2986483
less than 5 bone metastases location (including spinal) or lymph node.
Description

Secondary malignant neoplasm of bone Location Quantity | Secondary malignant neoplasm of spinal cord | Secondary malignant neoplasm of lymph node

Data type

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0347016
UMLS CUI [3]
C0686619
without other metastases or recurrences by choline pet or / and nmr diffusion length.
Description

Neoplasm Metastasis Other Absent | Recurrence Other Absent | Choline PET | NMR

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0034897
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0008405
UMLS CUI [3,2]
C0032743
UMLS CUI [4]
C0024485
signed and dated written informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes.
Description

abiraterone | enzalutamide | Chemotherapy | Immunotherapy | Radioisotopes

Data type

boolean

Alias
UMLS CUI [1]
C0754011
UMLS CUI [2]
C3496793
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0034595
patients unwilling or unable to comply with protocol requirements and scheduled visits.
Description

Protocol Compliance Unwilling | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Oligometastatic Prostate Cancer NCT02192788

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma | Neoplasm Metastasis Few Post Primary treatment | Recurrence Few Post Primary treatment
Item
patients with histologically confirmed prostate cancer, who are currently being oligometastases / oligorrecurrencia after primary treatment for their disease.
boolean
C0600139 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0205388 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C1708063 (UMLS CUI [2,4])
C0034897 (UMLS CUI [3,1])
C0205388 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C1708063 (UMLS CUI [3,4])
Age
Item
aged ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Time Interval Recurrence Biochemical
Item
time to biochemical recurrence more than 1 year
boolean
C0872291 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0205474 (UMLS CUI [1,3])
Prostate-Specific Antigen Doubling Time
Item
psa doubling time> 3 months
boolean
C0138741 (UMLS CUI [1,1])
C2986483 (UMLS CUI [1,2])
Secondary malignant neoplasm of bone Location Quantity | Secondary malignant neoplasm of spinal cord | Secondary malignant neoplasm of lymph node
Item
less than 5 bone metastases location (including spinal) or lymph node.
boolean
C0153690 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0347016 (UMLS CUI [2])
C0686619 (UMLS CUI [3])
Neoplasm Metastasis Other Absent | Recurrence Other Absent | Choline PET | NMR
Item
without other metastases or recurrences by choline pet or / and nmr diffusion length.
boolean
C0027627 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0034897 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0008405 (UMLS CUI [3,1])
C0032743 (UMLS CUI [3,2])
C0024485 (UMLS CUI [4])
Informed Consent
Item
signed and dated written informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
abiraterone | enzalutamide | Chemotherapy | Immunotherapy | Radioisotopes
Item
patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes.
boolean
C0754011 (UMLS CUI [1])
C3496793 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0034595 (UMLS CUI [5])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
patients unwilling or unable to comply with protocol requirements and scheduled visits.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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