ID

39893

Description

Chemotherapy Response Monitoring With 18F-choline PET/CT in Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00928252

Link

https://clinicaltrials.gov/show/NCT00928252

Keywords

Versions (1)
  1. 3/1/20 3/1/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 1, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hormone Refractory Prostate Cancer NCT00928252

English

Eligibility Hormone Refractory Prostate Cancer NCT00928252

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer
Description

Gender | Age | Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0600139
3. history of treatment by complete androgen blockade for greater than 3 months prior to enrollment
Description

Total Androgen Blockade

Data type

boolean

Alias
UMLS CUI [1]
C2986598
4. progressive disease evidenced by 2 consecutive rises in psa measured at least 1 week apart, with the absolute value of the latest psa > 5.0 ng/ml.
Description

Progressive Disease | Raised prostate specific antigen Quantity | Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0201544
5. a rise in psa following anti-androgen drug withdrawal, above the last psa value before withdrawal.
Description

Raised prostate specific antigen | Status post Androgen Antagonist Withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0002842
UMLS CUI [2,3]
C2349954
6. patient has agreed to treatment for hormone-refractory (ie. castrate-resistant) prostate cancer under supervision of a medical oncologist, urologist, radiation oncologist or nuclear medicine physician. treatments indicated for hrpc are docetaxel-, cabazitaxel-, or mitoxantrone-based chemotherapy, abiraterone, radium-223, enzalutamide, or sipulecuil-t.
Description

Therapeutic procedure Hormone refractory prostate cancer | Chemotherapy Docetaxel Based | Chemotherapy Cabazitaxel Based | Chemotherapy Mitoxantrone Based | abiraterone | Radium-223 | enzalutamide | sipuleucel-T

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1328504
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0246415
UMLS CUI [2,3]
C1705938
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C2830183
UMLS CUI [3,3]
C1705938
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0026259
UMLS CUI [4,3]
C1705938
UMLS CUI [5]
C0754011
UMLS CUI [6]
C0303282
UMLS CUI [7]
C3496793
UMLS CUI [8]
C1706668
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
Description

Cancer Other | Exception Basal cell carcinoma | Exception Superficial transitional cell carcinoma of bladder

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279680
UMLS CUI [3,3]
C0205124
2. serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging.
Description

Medical condition Serious Impairing Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0221099
UMLS CUI [1,4]
C0011923
3. patient weighs over 350 lbs (due to scanner weight limit).
Description

High weight

Data type

boolean

Alias
UMLS CUI [1]
C0948775
4. clinical life expectancy < 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
5. participated in other radioactive drug studies where estimated total cumulative dose within 1 year is > 0.05 sievert for whole body, active blood-forming organs, eye lens, gonads, or 0.15 sievert for other organs.
Description

Study Subject Participation Status | Radiopharmaceuticals Cumulative Dose per year Estimated

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0182638
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0439508
UMLS CUI [2,4]
C0750572
6. concurrent therapy. allowed: prior or concurrent chemotherapy, but must be > 12 weeks since last treatment at enrollment; prior or concurrent hormonal therapy; prior surgery; prior or concurrent bisphosphonate; prior or concurrent receptor/biologic agent allowed if given on approved study protocol.
Description

Concurrent therapy allowed | Prior Chemotherapy allowed | Hormone Therapy | Prior surgery | Diphosphonates | Biological agents allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0683607
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0455610
UMLS CUI [5]
C0012544
UMLS CUI [6,1]
C0005515
UMLS CUI [6,2]
C0683607
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Similar models

Eligibility Hormone Refractory Prostate Cancer NCT00928252

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. provision of written informed consent.
boolean
C0021430 (UMLS CUI [1])
Gender | Age | Prostate carcinoma
Item
2. men, over 18 years of age, with histologically-confirmed diagnosis of prostate cancer
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0600139 (UMLS CUI [3])
Total Androgen Blockade
Item
3. history of treatment by complete androgen blockade for greater than 3 months prior to enrollment
boolean
C2986598 (UMLS CUI [1])
Progressive Disease | Raised prostate specific antigen Quantity | Prostate specific antigen measurement
Item
4. progressive disease evidenced by 2 consecutive rises in psa measured at least 1 week apart, with the absolute value of the latest psa > 5.0 ng/ml.
boolean
C1335499 (UMLS CUI [1])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])
Raised prostate specific antigen | Status post Androgen Antagonist Withdrawal
Item
5. a rise in psa following anti-androgen drug withdrawal, above the last psa value before withdrawal.
boolean
C0178415 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0002842 (UMLS CUI [2,2])
C2349954 (UMLS CUI [2,3])
Therapeutic procedure Hormone refractory prostate cancer | Chemotherapy Docetaxel Based | Chemotherapy Cabazitaxel Based | Chemotherapy Mitoxantrone Based | abiraterone | Radium-223 | enzalutamide | sipuleucel-T
Item
6. patient has agreed to treatment for hormone-refractory (ie. castrate-resistant) prostate cancer under supervision of a medical oncologist, urologist, radiation oncologist or nuclear medicine physician. treatments indicated for hrpc are docetaxel-, cabazitaxel-, or mitoxantrone-based chemotherapy, abiraterone, radium-223, enzalutamide, or sipulecuil-t.
boolean
C0087111 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C1705938 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C2830183 (UMLS CUI [3,2])
C1705938 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0026259 (UMLS CUI [4,2])
C1705938 (UMLS CUI [4,3])
C0754011 (UMLS CUI [5])
C0303282 (UMLS CUI [6])
C3496793 (UMLS CUI [7])
C1706668 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Basal cell carcinoma | Exception Superficial transitional cell carcinoma of bladder
Item
1. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0279680 (UMLS CUI [3,2])
C0205124 (UMLS CUI [3,3])
Medical condition Serious Impairing Imaging
Item
2. serious underlying medical conditions that would otherwise impair the patient's ability to undergo imaging.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0011923 (UMLS CUI [1,4])
High weight
Item
3. patient weighs over 350 lbs (due to scanner weight limit).
boolean
C0948775 (UMLS CUI [1])
Life Expectancy
Item
4. clinical life expectancy < 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status | Radiopharmaceuticals Cumulative Dose per year Estimated
Item
5. participated in other radioactive drug studies where estimated total cumulative dose within 1 year is > 0.05 sievert for whole body, active blood-forming organs, eye lens, gonads, or 0.15 sievert for other organs.
boolean
C2348568 (UMLS CUI [1])
C0182638 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0439508 (UMLS CUI [2,3])
C0750572 (UMLS CUI [2,4])
Concurrent therapy allowed | Prior Chemotherapy allowed | Hormone Therapy | Prior surgery | Diphosphonates | Biological agents allowed
Item
6. concurrent therapy. allowed: prior or concurrent chemotherapy, but must be > 12 weeks since last treatment at enrollment; prior or concurrent hormonal therapy; prior surgery; prior or concurrent bisphosphonate; prior or concurrent receptor/biologic agent allowed if given on approved study protocol.
boolean
C0009429 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3])
C0455610 (UMLS CUI [4])
C0012544 (UMLS CUI [5])
C0005515 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
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