ID

17177

Description

Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00499421

Link

https://clinicaltrials.gov/show/NCT00499421

Keywords

Versions (1)
  1. 8/30/16 8/30/16 -
Uploaded on

August 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00499421

English

Eligibility Prostate Cancer NCT00499421

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with pathologic diagnosis of prostate cancer.
Description

prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C0600139
2. patients must plan to have external beam radiation as the definitive treatment for their prostate cancer with daily localization.
Description

external beam radiation

Data type

boolean

Alias
UMLS CUI [1]
C0419095
3. patients must be able to tolerate transrectal or transperineal implantation of three fiducial markers into the prostate.
Description

transrectal or transperineal implantation of fiducial markers

Data type

boolean

Alias
UMLS CUI [1,1]
C2826325
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C0205518
UMLS CUI [2,1]
C2826325
UMLS CUI [2,2]
C0021107
UMLS CUI [2,3]
C0205500
4. patients must be able to tolerate frequent (e.g. three ct scans per week) ct scanning.
Description

CT scan

Data type

boolean

Alias
UMLS CUI [1]
C0040405
5. patients must be able to lie flat and still for the duration of the fiducial-based localization and ct scanning sessions.
Description

able to lie flat and still

Data type

boolean

Alias
UMLS CUI [1]
C0560840
6. patients must have anatomy that will allow an adequate pelvic image on portal imaging and ct scanning.
Description

adequate pelvic image on portal imaging and ct scanning

Data type

boolean

Alias
UMLS CUI [1,1]
C3703842
UMLS CUI [1,2]
C0205411
7. if patients received hormone therapy, then it must have started more than 8 weeks prior to implantation of fiducials.
Description

hormone therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
8. patients on hormonal therapy at the time of simulation must remain on hormone therapy until their radiation course is complete.
Description

hormonal therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
9. patients must understand and sign informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who are not candidates for trans-rectal prostate biopsy or cannot tolerate placement of three fiducial prostate markers.
Description

patients not candidates for trans-rectal prostate biopsy or cannot tolerate placement of fiducial prostate markers

Data type

boolean

Alias
UMLS CUI [1]
C0401641
UMLS CUI [2,1]
C2826325
UMLS CUI [2,2]
C0021107
2. patients with an estimated prostate volume of less than 20 cc.
Description

prostate volume

Data type

boolean

Alias
UMLS CUI [1]
C1441416
3. patients who have had prior prostate surgery or are planned to have prostate surgery for prostate cancer.
Description

prostate surgery

Data type

boolean

Alias
UMLS CUI [1]
C0194790
4. patients who have had previous radiation therapy to the pelvis.
Description

radiation therapy to the pelvis

Data type

boolean

Alias
UMLS CUI [1]
C0747411
5. patients who have had prior prostate brachytherapy implant or who have a planned course of therapy using prostate brachytherapy (permanent seeds or high dose rate).
Description

prostate brachytherapy

Data type

boolean

Alias
UMLS CUI [1]
C0854662
6. patients with a body habitus that the ct bore of the ct/linac treatment machine cannot accommodate (i.e. height greater than 6' 3" or body weight greater than 300 pounds).
Description

Height, body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005890
UMLS CUI [2]
C0005910
7. patients on anticoagulant medication (e.g., coumadin, clopidogrel, low-molecular weight heparin) other than aspirin will not be eligible. patients on aspirin should discontinue aspirin 7 days prior to fiducial placement and for 5 days afterward.
Description

anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
8. patients with hip prostheses will not be eligible.
Description

hip prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0019560
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Similar models

Eligibility Prostate Cancer NCT00499421

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
prostate cancer
Item
1. patients with pathologic diagnosis of prostate cancer.
boolean
C0600139 (UMLS CUI [1])
external beam radiation
Item
2. patients must plan to have external beam radiation as the definitive treatment for their prostate cancer with daily localization.
boolean
C0419095 (UMLS CUI [1])
transrectal or transperineal implantation of fiducial markers
Item
3. patients must be able to tolerate transrectal or transperineal implantation of three fiducial markers into the prostate.
boolean
C2826325 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C0205518 (UMLS CUI [1,3])
C2826325 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
C0205500 (UMLS CUI [2,3])
CT scan
Item
4. patients must be able to tolerate frequent (e.g. three ct scans per week) ct scanning.
boolean
C0040405 (UMLS CUI [1])
able to lie flat and still
Item
5. patients must be able to lie flat and still for the duration of the fiducial-based localization and ct scanning sessions.
boolean
C0560840 (UMLS CUI [1])
adequate pelvic image on portal imaging and ct scanning
Item
6. patients must have anatomy that will allow an adequate pelvic image on portal imaging and ct scanning.
boolean
C3703842 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
hormone therapy
Item
7. if patients received hormone therapy, then it must have started more than 8 weeks prior to implantation of fiducials.
boolean
C0279025 (UMLS CUI [1])
hormonal therapy
Item
8. patients on hormonal therapy at the time of simulation must remain on hormone therapy until their radiation course is complete.
boolean
C0279025 (UMLS CUI [1])
Informed Consent
Item
9. patients must understand and sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
patients not candidates for trans-rectal prostate biopsy or cannot tolerate placement of fiducial prostate markers
Item
1. patients who are not candidates for trans-rectal prostate biopsy or cannot tolerate placement of three fiducial prostate markers.
boolean
C0401641 (UMLS CUI [1])
C2826325 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
prostate volume
Item
2. patients with an estimated prostate volume of less than 20 cc.
boolean
C1441416 (UMLS CUI [1])
prostate surgery
Item
3. patients who have had prior prostate surgery or are planned to have prostate surgery for prostate cancer.
boolean
C0194790 (UMLS CUI [1])
radiation therapy to the pelvis
Item
4. patients who have had previous radiation therapy to the pelvis.
boolean
C0747411 (UMLS CUI [1])
prostate brachytherapy
Item
5. patients who have had prior prostate brachytherapy implant or who have a planned course of therapy using prostate brachytherapy (permanent seeds or high dose rate).
boolean
C0854662 (UMLS CUI [1])
Height, body weight
Item
6. patients with a body habitus that the ct bore of the ct/linac treatment machine cannot accommodate (i.e. height greater than 6' 3" or body weight greater than 300 pounds).
boolean
C0005890 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
anticoagulants
Item
7. patients on anticoagulant medication (e.g., coumadin, clopidogrel, low-molecular weight heparin) other than aspirin will not be eligible. patients on aspirin should discontinue aspirin 7 days prior to fiducial placement and for 5 days afterward.
boolean
C0003280 (UMLS CUI [1])
hip prosthesis
Item
8. patients with hip prostheses will not be eligible.
boolean
C0019560 (UMLS CUI [1])
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