ID

36850

Beschreibung

Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02036918

Link

https://clinicaltrials.gov/show/NCT02036918

Stichworte

Versionen (1)
  1. 16.06.19 16.06.19 -
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See clinicaltrials.gov

Hochgeladen am

16. Juni 2019

DOI

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Lizenz

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Eligibility Prostate Cancer NCT02036918

Englisch

Eligibility Prostate Cancer NCT02036918

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. ecog performance status 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
3. life expectancy of ≥ 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
4. minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
Beschreibung

Hormone refractory prostate cancer metastatic minimal symptomatic | Hormone refractory prostate cancer metastatic asymptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1328504
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C0547040
UMLS CUI [1,4]
C0231220
UMLS CUI [2,1]
C1328504
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C0231221
1. histologically-confirmed diagnosis of adenocarcinoma of the prostate
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
2. evidence of adequate androgen deprivation, as evidence by one of the following:
Beschreibung

Androgen suppression

Datentyp

boolean

Alias
UMLS CUI [1]
C1515985
bilateral orchiectomy
Beschreibung

Male Castration

Datentyp

boolean

Alias
UMLS CUI [1]
C0007347
ongoing lhrh agonist (e.g. leuprolide, goserelin) and serum testosterone <50 ng/dl
Beschreibung

Luteinizing Hormone-releasing Hormone Agonist | Leuprolide | Goserelin

Datentyp

boolean

Alias
UMLS CUI [1]
C1518041
UMLS CUI [2]
C0085272
UMLS CUI [3]
C0120107
ongoing lhrh antagonist (e.g. degarelix) and serum testosterone <50 ng/dl
Beschreibung

Luteinizing hormone releasing hormone antagonist product | degarelix | Serum testosterone measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1276926
UMLS CUI [2]
C1455035
UMLS CUI [3]
C0428413
3. evidence of prostate cancer resistance to castration, as evidenced by one of the following:
Beschreibung

Hormone refractory prostate cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C1328504
2 consecutive psa levels that are ≥ 50% above the psa nadir achieved on adt and obtained at least 1 week apart
Beschreibung

Raised prostate specific antigen | PSA Level Nadir Antiandrogen therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2,1]
C4086720
UMLS CUI [2,2]
C1708760
UMLS CUI [2,3]
C0279492
ct or mri based evidence of disease progression (soft tissue or nodal) according to pcwg2 criteria or recist 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
Beschreibung

Disease Progression Soft tissue CT | Disease Progression Soft tissue MRI | Disease Progression Lymph nodes CT | Disease Progression Lymph nodes MRI | Lesion New Quantity Bone scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0225317
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0225317
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0024204
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0024204
UMLS CUI [4,3]
C0024485
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C0205314
UMLS CUI [5,3]
C1265611
UMLS CUI [5,4]
C0203668
4. presence of non-visceral metastases on imaging
Beschreibung

Neoplasm Metastasis Non-Visceral Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1518392
UMLS CUI [1,3]
C0011923
5. absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:
Beschreibung

Absence Symptoms Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0600139
ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy
Beschreibung

Exception | Ureteral obstruction Secondary to Pelvic lymphadenopathy | Ureteral obstruction Secondary to Retroperitoneal lymphadenopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0041956
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C1264124
UMLS CUI [3,1]
C0041956
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0748390
bladder outlet obstruction secondary to locally recurrent prostate cancer
Beschreibung

Exception | Bladder neck obstruction Secondary to Prostate cancer recurrent Locally

Datentyp

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0005694
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0278838
UMLS CUI [2,4]
C1517927
5. radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (ct or mri or pet/ct)
Beschreibung

Lymphadenopathy Radiography | Lymph node Diameter CT | Lymph node Diameter MRI | Lymph node Diameter PET/CT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0034571
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0024204
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0024485
UMLS CUI [4,1]
C0024204
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C1699633
6. adequate laboratory parameters
Beschreibung

Laboratory Parameters

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0449381
7. a minimum of 4 weeks from any major surgery prior to registration. coincident standard of care surgery with the research biopsy is permitted during the study.
Beschreibung

Major surgery Previous | Standard of Care Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0543467
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with sipuleucel-t
Beschreibung

sipuleucel-T

Datentyp

boolean

Alias
UMLS CUI [1]
C1706668
2. allergy to any component of sipuleucel-t
Beschreibung

Hypersensitivity Sipuleucel-T Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1706668
UMLS CUI [1,3]
C1705248
3. inability to undergo leukapheresis
Beschreibung

Leukapheresis Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023416
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
4. history of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
Beschreibung

Prostate Neuroendocrine Neoplasm | Small cell carcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C1335515
UMLS CUI [2]
C1300585
5. extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
Beschreibung

Extensive surgical procedure Biopsy Complex | Prior Extensive Radiation Biopsy Complex | Extensive surgical procedure High risk of Intraoperative injury | Prior Extensive Radiation High risk of Intraoperative injury

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4060998
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0439855
UMLS CUI [2,1]
C1514458
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0439855
UMLS CUI [3,1]
C4060998
UMLS CUI [3,2]
C0332167
UMLS CUI [3,3]
C1558210
UMLS CUI [4,1]
C1514458
UMLS CUI [4,2]
C0332167
UMLS CUI [4,3]
C1558210
6. any chronic medical condition requiring daily corticosteroids or other immunosuppressants
Beschreibung

Chronic disease Requirement Adrenal Cortex Hormones Daily | Chronic disease Requirement Immunosuppressive Agents Daily

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
UMLS CUI [1,4]
C0332173
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021081
UMLS CUI [2,4]
C0332173
7. solid organ transplantation requiring immunosuppression
Beschreibung

Solid organ transplant Requirement Therapeutic immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0730400
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
8. visceral (e.g. lung, liver) metastases
Beschreibung

Neoplasm Metastasis Visceral | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
UMLS CUI [2]
C0153676
UMLS CUI [3]
C0494165
9. known brain metastases
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
10. history of spinal cord compression
Beschreibung

Compression of spinal cord

Datentyp

boolean

Alias
UMLS CUI [1]
C0037926
11. untreated/unstabilized pathologic long bone fractures
Beschreibung

Fractures of the long bones Untreated | Stabilization Lacking Fractures of the long bones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240231
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1293130
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0240231
12. other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
Beschreibung

Cancer Other | Exception Skin carcinoma | Probability Percentage Recurrence

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C0033204
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0034897
13. administration of any investigational therapeutic within 30 days of registration
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
14. any condition which, in the opinion of the investigator, would preclude participation in this trial
Beschreibung

Condition Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
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Ähnliche Modelle

Eligibility Prostate Cancer NCT02036918

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy of ≥ 6 months
boolean
C0023671 (UMLS CUI [1])
Hormone refractory prostate cancer metastatic minimal symptomatic | Hormone refractory prostate cancer metastatic asymptomatic
Item
4. minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
boolean
C1328504 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0547040 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
C1328504 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
Adenocarcinoma of prostate
Item
1. histologically-confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Androgen suppression
Item
2. evidence of adequate androgen deprivation, as evidence by one of the following:
boolean
C1515985 (UMLS CUI [1])
Male Castration
Item
bilateral orchiectomy
boolean
C0007347 (UMLS CUI [1])
Luteinizing Hormone-releasing Hormone Agonist | Leuprolide | Goserelin
Item
ongoing lhrh agonist (e.g. leuprolide, goserelin) and serum testosterone <50 ng/dl
boolean
C1518041 (UMLS CUI [1])
C0085272 (UMLS CUI [2])
C0120107 (UMLS CUI [3])
Luteinizing hormone releasing hormone antagonist product | degarelix | Serum testosterone measurement
Item
ongoing lhrh antagonist (e.g. degarelix) and serum testosterone <50 ng/dl
boolean
C1276926 (UMLS CUI [1])
C1455035 (UMLS CUI [2])
C0428413 (UMLS CUI [3])
Hormone refractory prostate cancer
Item
3. evidence of prostate cancer resistance to castration, as evidenced by one of the following:
boolean
C1328504 (UMLS CUI [1])
Raised prostate specific antigen | PSA Level Nadir Antiandrogen therapy
Item
2 consecutive psa levels that are ≥ 50% above the psa nadir achieved on adt and obtained at least 1 week apart
boolean
C0178415 (UMLS CUI [1])
C4086720 (UMLS CUI [2,1])
C1708760 (UMLS CUI [2,2])
C0279492 (UMLS CUI [2,3])
Disease Progression Soft tissue CT | Disease Progression Soft tissue MRI | Disease Progression Lymph nodes CT | Disease Progression Lymph nodes MRI | Lesion New Quantity Bone scan
Item
ct or mri based evidence of disease progression (soft tissue or nodal) according to pcwg2 criteria or recist 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
boolean
C0242656 (UMLS CUI [1,1])
C0225317 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0225317 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4,1])
C0024204 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C0205314 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0203668 (UMLS CUI [5,4])
Neoplasm Metastasis Non-Visceral Imaging
Item
4. presence of non-visceral metastases on imaging
boolean
C0027627 (UMLS CUI [1,1])
C1518392 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Absence Symptoms Prostate carcinoma
Item
5. absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:
boolean
C0332197 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Exception | Ureteral obstruction Secondary to Pelvic lymphadenopathy | Ureteral obstruction Secondary to Retroperitoneal lymphadenopathy
Item
ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy
boolean
C1705847 (UMLS CUI [1])
C0041956 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C1264124 (UMLS CUI [2,3])
C0041956 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0748390 (UMLS CUI [3,3])
Exception | Bladder neck obstruction Secondary to Prostate cancer recurrent Locally
Item
bladder outlet obstruction secondary to locally recurrent prostate cancer
boolean
C1705847 (UMLS CUI [1])
C0005694 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0278838 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
Lymphadenopathy Radiography | Lymph node Diameter CT | Lymph node Diameter MRI | Lymph node Diameter PET/CT
Item
5. radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (ct or mri or pet/ct)
boolean
C0497156 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0024204 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0024204 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C1699633 (UMLS CUI [4,3])
Laboratory Parameters
Item
6. adequate laboratory parameters
boolean
C0022877 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
Major surgery Previous | Standard of Care Operative Surgical Procedures
Item
7. a minimum of 4 weeks from any major surgery prior to registration. coincident standard of care surgery with the research biopsy is permitted during the study.
boolean
C0679637 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
sipuleucel-T
Item
1. prior treatment with sipuleucel-t
boolean
C1706668 (UMLS CUI [1])
Hypersensitivity Sipuleucel-T Component
Item
2. allergy to any component of sipuleucel-t
boolean
C0020517 (UMLS CUI [1,1])
C1706668 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Leukapheresis Receive Unable
Item
3. inability to undergo leukapheresis
boolean
C0023416 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Prostate Neuroendocrine Neoplasm | Small cell carcinoma of prostate
Item
4. history of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
boolean
C1335515 (UMLS CUI [1])
C1300585 (UMLS CUI [2])
Extensive surgical procedure Biopsy Complex | Prior Extensive Radiation Biopsy Complex | Extensive surgical procedure High risk of Intraoperative injury | Prior Extensive Radiation High risk of Intraoperative injury
Item
5. extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
boolean
C4060998 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0439855 (UMLS CUI [1,3])
C1514458 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0439855 (UMLS CUI [2,3])
C4060998 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C1558210 (UMLS CUI [3,3])
C1514458 (UMLS CUI [4,1])
C0332167 (UMLS CUI [4,2])
C1558210 (UMLS CUI [4,3])
Chronic disease Requirement Adrenal Cortex Hormones Daily | Chronic disease Requirement Immunosuppressive Agents Daily
Item
6. any chronic medical condition requiring daily corticosteroids or other immunosuppressants
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
Solid organ transplant Requirement Therapeutic immunosuppression
Item
7. solid organ transplantation requiring immunosuppression
boolean
C0730400 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Neoplasm Metastasis Visceral | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver
Item
8. visceral (e.g. lung, liver) metastases
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0153676 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
9. known brain metastases
boolean
C0220650 (UMLS CUI [1])
Compression of spinal cord
Item
10. history of spinal cord compression
boolean
C0037926 (UMLS CUI [1])
Fractures of the long bones Untreated | Stabilization Lacking Fractures of the long bones
Item
11. untreated/unstabilized pathologic long bone fractures
boolean
C0240231 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1293130 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0240231 (UMLS CUI [2,3])
Cancer Other | Exception Skin carcinoma | Probability Percentage Recurrence
Item
12. other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0033204 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0034897 (UMLS CUI [3,3])
Investigational New Drugs
Item
13. administration of any investigational therapeutic within 30 days of registration
boolean
C0013230 (UMLS CUI [1])
Condition Study Subject Participation Status Excluded
Item
14. any condition which, in the opinion of the investigator, would preclude participation in this trial
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
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