ID

12166

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02269982

Keywords

versioni (1)
  1. 01/10/15 01/10/15 - Julian Varghese
Caricato su

1 ottobre 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02269982

Inglese

Eligibility Prostate Cancer NCT02269982

1 moduli  
Inclusion Criteria
Descrizione

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.
Descrizione

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

Tipo di dati

boolean

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

metastatic disease

Tipo di dati

boolean

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

therapy; planned

Tipo di dati

boolean

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

levels of testosterone

Tipo di dati

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).
Descrizione

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

Tipo di dati

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:
Descrizione

disease progression; screening; high risk

Tipo di dati

boolean

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

anemia with a hemoglobin <12.0 g/dl

Tipo di dati

boolean

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

Alkaline Phosphatase

Tipo di dati

boolean

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

Lactate dehydrogenase measurement

Tipo di dati

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.
Descrizione

prior therapy with either enzalutamide or abiraterone acetate; converse therapy

Tipo di dati

boolean

5. presence of visceral metastasis on imaging
Descrizione

presence of visceral metastasis

Tipo di dati

boolean

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

opioid analgesia

Tipo di dati

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
Descrizione

cellsearch ctc

Tipo di dati

boolean

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

psa

Tipo di dati

boolean

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

age > 18

Tipo di dati

boolean

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

willingness to sign a written informed consent document

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

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).
Descrizione

Protocol Compliance; Comorbidity | Mental disorders

Tipo di dati

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
Descrizione

anthracycline or mitoxantrone

Tipo di dati

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.
Descrizione

metastatic; docetaxel; disease

Tipo di dati

boolean

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

protocol compliance

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0525058
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Similar models

Eligibility Prostate Cancer NCT02269982

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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