ID

12166

Description

Development of Circulating Molecular Predictors of Chemotherapy and Novel Hormonal Therapy Benefit in Men With Metastatic Castration Resistant Prostate Cancer (mCRPC) (PCF); ODM derived from: https://clinicaltrials.gov/show/NCT02269982

Link

https://clinicaltrials.gov/show/NCT02269982

Keywords

Versions (1)
  1. 10/1/15 10/1/15 - Julian Varghese
Uploaded on

October 1, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02269982

English

Eligibility Prostate Cancer NCT02269982

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed diagnosis of adenocarcinoma of the prostate. pure small cell or neuroendocrine tumors of the prostate are not permitted.
Description

Adenocarcinoma of prostate | Small cell carcinoma of prostate | Prostate Neuroendocrine Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C1300585
UMLS CUI [3]
C1335515
2. clinical or radiographic evidence of metastatic disease.
Description

metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0027627
3. planned therapy with either enzalutamide and/or abiraterone acetate within the coming 6 weeks
Description

therapy; planned

Data type

boolean

Alias
UMLS CUI [1]
C3496793
UMLS CUI [2]
C2607886
4. castrate levels of testosterone (<50 ng/dl) at most recent assessment.
Description

levels of testosterone

Data type

boolean

Alias
UMLS CUI [1]
C0428413
5. evidence of disease progression on or following most recent therapy as evidenced by the following: • radiographic evidence of disease progression as defined by one or more new bone scan lesions that is not consistent with flare/healing, or growth of soft tissue/visceral metastases to greater than one centimeter (cm) in longest diameter (2 cm shortest diameter for lymph nodes).
Description

disease progression; evidence of disease; longest diameter; lymph nodes; radiographic; soft tissue; centimeter; metastases; bone scan; lesions; new

Data type

boolean

Alias
UMLS CUI [1]
C0238792
UMLS CUI [2]
C0347001
6. at least two of the following high risk features during screening for rapid disease progression:
Description

disease progression; screening; high risk

Data type

boolean

1. anemia with a hemoglobin <12.0 g/dl
Description

anemia with a hemoglobin <12.0 g/dl

Data type

boolean

Alias
UMLS CUI [1]
C0019046
2. elevated alkaline phosphatase above the institution upper limit of normal
Description

Alkaline Phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0002059
3. high lactate dehydrogenase (ldh) above the upper limit of normal
Description

Lactate dehydrogenase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202113
4. prior therapy with either enzalutamide or abiraterone acetate in patients planned to receive the converse therapy. patients are not permitted if they are continuing on the same therapy or restarting a therapy that they have been exposed to in the past.
Description

prior therapy with either enzalutamide or abiraterone acetate; converse therapy

Data type

boolean

5. presence of visceral metastasis on imaging
Description

presence of visceral metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
6. presence of clinically significant pain requiring opioid analgesia
Description

opioid analgesia

Data type

boolean

Alias
UMLS CUI [1]
C0242402
7. patients with a cellsearch ctc > 5 cells per 7.5 ml whole blood (if available as standard of care) are eligible without additional high risk features
Description

cellsearch ctc

Data type

boolean

Alias
UMLS CUI [1]
C0027625
8. psa doubling time under 3 months on most recent therapy
Description

psa

Data type

boolean

Alias
UMLS CUI [1]
C0138741
7. age > 18 years.
Description

age > 18

Data type

boolean

Alias
UMLS CUI [1]
C0001779
8. ability to understand and the willingness to sign a written informed consent document.
Description

willingness to sign a written informed consent document

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
Description

Protocol Compliance; Comorbidity | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0009488
UMLS CUI [2]
C0004936
2. treatment with an anthracycline or mitoxantrone within 1 week of ctc collection
Description

anthracycline or mitoxantrone

Data type

boolean

Alias
UMLS CUI [1]
C0026259
UMLS CUI [2]
C0282564
3. prior docetaxel in the castration resistant metastatic setting. patients treated with docetaxel for metastatic castration sensitive disease will be eligible.
Description

metastatic; docetaxel; disease

Data type

boolean

Alias
UMLS CUI [1]
C0246415
4. unwillingness to be followed longitudinally for serial ctc biomarker studies.
Description

protocol compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
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Similar models

Eligibility Prostate Cancer NCT02269982

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Small cell carcinoma of prostate | Prostate Neuroendocrine Neoplasm
Item
1. histologically confirmed diagnosis of adenocarcinoma of the prostate. pure small cell or neuroendocrine tumors of the prostate are not permitted.
boolean
C0007112 (UMLS CUI [1])
C1300585 (UMLS CUI [2])
C1335515 (UMLS CUI [3])
metastatic disease
Item
2. clinical or radiographic evidence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
therapy; planned
Item
3. planned therapy with either enzalutamide and/or abiraterone acetate within the coming 6 weeks
boolean
C3496793 (UMLS CUI [1])
C2607886 (UMLS CUI [2])
levels of testosterone
Item
4. castrate levels of testosterone (<50 ng/dl) at most recent assessment.
boolean
C0428413 (UMLS CUI [1])
disease progression; evidence of disease; longest diameter; lymph nodes; radiographic; soft tissue; centimeter; metastases; bone scan; lesions; new
Item
5. evidence of disease progression on or following most recent therapy as evidenced by the following: • radiographic evidence of disease progression as defined by one or more new bone scan lesions that is not consistent with flare/healing, or growth of soft tissue/visceral metastases to greater than one centimeter (cm) in longest diameter (2 cm shortest diameter for lymph nodes).
boolean
C0238792 (UMLS CUI [1])
C0347001 (UMLS CUI [2])
disease progression; screening; high risk
Item
6. at least two of the following high risk features during screening for rapid disease progression:
boolean
anemia with a hemoglobin <12.0 g/dl
Item
1. anemia with a hemoglobin <12.0 g/dl
boolean
C0019046 (UMLS CUI [1])
Alkaline Phosphatase
Item
2. elevated alkaline phosphatase above the institution upper limit of normal
boolean
C0002059 (UMLS CUI [1])
Lactate dehydrogenase measurement
Item
3. high lactate dehydrogenase (ldh) above the upper limit of normal
boolean
C0202113 (UMLS CUI [1])
prior therapy with either enzalutamide or abiraterone acetate; converse therapy
Item
4. prior therapy with either enzalutamide or abiraterone acetate in patients planned to receive the converse therapy. patients are not permitted if they are continuing on the same therapy or restarting a therapy that they have been exposed to in the past.
boolean
presence of visceral metastasis
Item
5. presence of visceral metastasis on imaging
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
opioid analgesia
Item
6. presence of clinically significant pain requiring opioid analgesia
boolean
C0242402 (UMLS CUI [1])
cellsearch ctc
Item
7. patients with a cellsearch ctc > 5 cells per 7.5 ml whole blood (if available as standard of care) are eligible without additional high risk features
boolean
C0027625 (UMLS CUI [1])
psa
Item
8. psa doubling time under 3 months on most recent therapy
boolean
C0138741 (UMLS CUI [1])
age > 18
Item
7. age > 18 years.
boolean
C0001779 (UMLS CUI [1])
willingness to sign a written informed consent document
Item
8. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Protocol Compliance; Comorbidity | Mental disorders
Item
1. history of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
boolean
C0525058 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
anthracycline or mitoxantrone
Item
2. treatment with an anthracycline or mitoxantrone within 1 week of ctc collection
boolean
C0026259 (UMLS CUI [1])
C0282564 (UMLS CUI [2])
metastatic; docetaxel; disease
Item
3. prior docetaxel in the castration resistant metastatic setting. patients treated with docetaxel for metastatic castration sensitive disease will be eligible.
boolean
C0246415 (UMLS CUI [1])
protocol compliance
Item
4. unwillingness to be followed longitudinally for serial ctc biomarker studies.
boolean
C0525058 (UMLS CUI [1])
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