ID

25064

Description

Radiation Therapy Followed by Surgery in High-Risk, Localized Carcinoma of the Prostate; ODM derived from: https://clinicaltrials.gov/show/NCT00691977

Link

https://clinicaltrials.gov/show/NCT00691977

Keywords

Versions (1)
  1. 8/25/17 8/25/17 -
Uploaded on

August 25, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00691977

English

Eligibility Prostate Cancer NCT00691977

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have biopsy-confirmed adenocarcinoma of the prostate.
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
subjects must have a negative bone scan.
Description

Bone scan Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0203668
UMLS CUI [1,2]
C1513916
subjects must have "high-risk" prostate cancer, defined as:
Description

High risk of Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0600139
a. psa >/= 20, and/or b. gleason score (gs) >/= 8, and/or c. clinical stage t3 disease per ajcc staging manual, 6th edition; or d. at least two out of three of the following: psa 10-19.9, gs = 7, or clinical stage = t2b / t2c.
Description

PSA measurement | Gleason score | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C3203027
UMLS CUI [3]
C3258246
subjects must be medically fit to undergo surgery as determined by treating urologist.
Description

Fit Receive Operative Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0543467
subjects must be under 70 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
kps must be >/= 80.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
subjects must not have a synchronous primary tumor, or a previous cancer unless disease free for >/= 5 years.
Description

Primary tumor Absent | Malignant Neoplasm Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332296
subjects must not have had prior pelvic radiation therapy, chemotherapy, or androgen deprivation.
Description

Radiotherapy to pelvis Absent | Chemotherapy Absent | Antiandrogen therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0279492
UMLS CUI [3,2]
C0332197
subjects must freely sign informed consent to enroll in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic disease as demonstrated by bone scan, ct scan or mri of the pelvis, or chest x-ray.
Description

Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT of Pelvis | Neoplasm Metastasis MRI of Pelvis | Neoplasm Metastasis Chest X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0412628
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0203201
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0039985
pathologically documented positive pelvic lymph nodes. if pre-operative ct scan or mri (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
Description

Pelvic lymph nodes Positive | CT scan Preoperative Pelvic lymph nodes | MRI Preoperative Pelvic lymph nodes | Biopsy Pelvic lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0729595
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C0445204
UMLS CUI [2,3]
C0729595
UMLS CUI [3,1]
C0024485
UMLS CUI [3,2]
C0445204
UMLS CUI [3,3]
C0729595
UMLS CUI [4,1]
C0005558
UMLS CUI [4,2]
C0729595
declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
Description

High risk Anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0002903
history of prior pelvic radiation therapy.
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
history of androgen deprivation therapy or chemotherapy.
Description

Antiandrogen therapy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C0392920
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Similar models

Eligibility Prostate Cancer NCT00691977

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
subjects must have biopsy-confirmed adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Bone scan Negative
Item
subjects must have a negative bone scan.
boolean
C0203668 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
High risk of Prostate carcinoma
Item
subjects must have "high-risk" prostate cancer, defined as:
boolean
C0332167 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
PSA measurement | Gleason score | TNM clinical staging
Item
a. psa >/= 20, and/or b. gleason score (gs) >/= 8, and/or c. clinical stage t3 disease per ajcc staging manual, 6th edition; or d. at least two out of three of the following: psa 10-19.9, gs = 7, or clinical stage = t2b / t2c.
boolean
C0201544 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C3258246 (UMLS CUI [3])
Fit Receive Operative Surgical Procedure
Item
subjects must be medically fit to undergo surgery as determined by treating urologist.
boolean
C0424576 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Age
Item
subjects must be under 70 years of age.
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps must be >/= 80.
boolean
C0206065 (UMLS CUI [1])
Primary tumor Absent | Malignant Neoplasm Free of
Item
subjects must not have a synchronous primary tumor, or a previous cancer unless disease free for >/= 5 years.
boolean
C0677930 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
Radiotherapy to pelvis Absent | Chemotherapy Absent | Antiandrogen therapy Absent
Item
subjects must not have had prior pelvic radiation therapy, chemotherapy, or androgen deprivation.
boolean
C1536155 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
subjects must freely sign informed consent to enroll in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT of Pelvis | Neoplasm Metastasis MRI of Pelvis | Neoplasm Metastasis Chest X-ray
Item
metastatic disease as demonstrated by bone scan, ct scan or mri of the pelvis, or chest x-ray.
boolean
C0027627 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0412628 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0203201 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0039985 (UMLS CUI [4,2])
Pelvic lymph nodes Positive | CT scan Preoperative Pelvic lymph nodes | MRI Preoperative Pelvic lymph nodes | Biopsy Pelvic lymph nodes
Item
pathologically documented positive pelvic lymph nodes. if pre-operative ct scan or mri (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
boolean
C0729595 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C0729595 (UMLS CUI [2,3])
C0024485 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
C0729595 (UMLS CUI [3,3])
C0005558 (UMLS CUI [4,1])
C0729595 (UMLS CUI [4,2])
High risk Anesthesia
Item
declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
boolean
C0332167 (UMLS CUI [1,1])
C0002903 (UMLS CUI [1,2])
Radiotherapy to pelvis
Item
history of prior pelvic radiation therapy.
boolean
C1536155 (UMLS CUI [1])
Antiandrogen therapy | Chemotherapy
Item
history of androgen deprivation therapy or chemotherapy.
boolean
C0279492 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
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