ID

20758

Descripción

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Palabras clave

Versiones (1)
  1. 15/3/17 15/3/17 -
Subido en

15 de marzo de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (End of screening-Eligibility)

Inglés

Radium 223 Dichloride (Alpharadin) - In- and Exclucsion criteria

1 formularios  
Inclusion criteria
Descripción

Inclusion criteria

Was the signed informed consent (IC) obtained before any study specific procedure? Subjects must be able to understand and be willing to sign the written informed consent form (ICF). A signed ICF must be appropriately obtained prior to the conduct of the trial specific procedure.
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1321605
Is the subject a male patient and 18 years of age?
Descripción

Age and gender

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0079399
Does the subject have histologically or cytologically confirmed prostate cancer?
Descripción

Confirmed diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0600139
Is the subject diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)?
Descripción

Metastatic disease, progressive disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0936223
UMLS CUI [1,2]
C0677932
UMLS CUI [1,3]
C0741600
Is the subject diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)?
Descripción

Metastatic disease, progressive disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0936223
UMLS CUI [1,2]
C0677932
UMLS CUI [1,3]
C0011923
Is the subject diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)? A standart of practice bone scan for the documentation of at least two skeletal metastases can be used as long as it is within 3 months of planned start of treatment. If no bone scan within a 3 months window is available, then a technetium-99m bone scan will be obtained at screening (within 28 days of planned start of study drug).
Descripción

Metastatic disease, progressive disease, metastasis documentation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0936223
UMLS CUI [1,2]
C0677932
UMLS CUI [1,3]
C0741600
UMLS CUI [2,1]
C0175636
UMLS CUI [2,2]
C0303611
UMLS CUI [2,3]
C0203668
Does the subject have progressive disease is defined either byThe appearance of new bone lesions. Ifprogression is based on new lesion(s) on bone scan only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; orln the absence ofnew bone lesions, by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA >= 5 ng/mL
Descripción

Progressive disease , bone lesion, PSA

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677932
UMLS CUI [1,2]
C0741600
UMLS CUI [1,3]
C0238792
UMLS CUI [1,4]
C0138741
Does the subject have progressive disease is defined either by the appearance of new bone lesions. Ifprogression is based on new lesion(s) on bone imaging only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; orln the absence ofnew bone lesions, by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA >= 5 ng/mL
Descripción

Progressive disease , bone lesion, PSA

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677932
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C0238792
UMLS CUI [1,4]
C0138741
Does the subject have a life expectancy >= 6 months?
Descripción

Life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
Does the subject have an Eastem Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2?
Descripción

ECOG performance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
Does the subject have adequate hematological, liver and renal function?absolute neutrophil count (ANC) >= 1.5 xl09/Lplatelet count >= 100 x 109/Lhemoglobin >= 10.0 g/dL (100 g/L; 6.2 mmol/L)total bilirubin level <= 1.5 x institutional upper limit of normal (ULN)aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<= 2.5 x ULNcreatinine <= 1.5 x ULNalbumin > 25 g/L
Descripción

Laboratory parameter, hematology, liver and renal function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0232804
UMLS CUI [1,4]
C0232741
Is the subject willing and able to comply with the protocol, including follow-up visits and examinations?
Descripción

Compliance behavior

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
Is the subject without intent to use cytotoxic chemotherapy within the next 6 months?
Descripción

Chemotherapy regimen

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0162425
Exclusion criteria
Descripción

Exclusion criteria

Did the subject have any treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up?
Descripción

Study subject participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
Is the subject eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available?
Descripción

First line treatment eligibility

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C1708063
Has the subject had treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)?
Descripción

Chemotherapy regimen, adverse events

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0877248
Has the subject had treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous prior to screening (however ongoing neuropathy is permitted)?
Descripción

Chemotherapy regimen, adverse events

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0877248
Has the subject received previous radiotherapy to approximately > 25percent of bone marrow, including hemibody radiation?
Descripción

Radiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
Has the subject had prior hemibody external radiotherapy? Patients who received other types of prior extemal radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for haemoglobin, absolute neutrophil count, and platelets.
Descripción

hemibody external radiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0419095
UMLS CUI [1,2]
C0206113
Has the subject received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases?
Descripción

Systemic therapy with radionuclides

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0203617
UMLS CUI [1,2]
C0205373
Has the subject had other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)?
Descripción

Other malignant neoplasm

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085183
Does the subject have Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)?
Descripción

Visceral metastases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
Does the subject have visceral metastases as assessed by abdominal or pelvic computed tomography (CT) ( or other imaging modality based on institutional standard ofcare)?
Descripción

Visceral metastases

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
Is there presence of brain metastases?
Descripción

brain metastases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
Does the subject have lymphadenopathy exceeding 6 cm in short-axis diameter?
Descripción

lymphadenopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497156
Does the subject have any size pelvic lymphadenopathy thought to be a contributor to concurrent hydronephrosis?
Descripción

pelvic lymphadenopathy, contributor to concurrent hydronephrosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1264124
UMLS CUI [1,2]
C0205420
UMLS CUI [1,3]
C0020295
Does the subject have imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)? Patients with history of spinal cord compression should have completely recovered.
Descripción

spinal cord compression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037926
Does the subject have any other serious illness or medical condition, such as but not limited to::Any infection >= NCI-CTCAE v.4.03 Grade 2? Cardiac failure New York Heart Association (NYHA) Class III or IV? Crohn's disease or ulcerative colitis? Bone marrow dysplasia?
Descripción

Concomitant condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0243086
Does the subject have fecal incontinence?
Descripción

fecal incontinence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015732
Has the subject had treatment with any prior anticancer therapy (including, therapeutic vaccines), other than the permitted Standard of Care therapies (please refer to section 6.9)? The Standard of Care therapies are allowed provided that they are completed 28 days before treatment or 5.5 half-lives ofthe drugs involved have elapsed before treatment start.
Descripción

Concomitant agent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0920425
End of screening
Descripción

End of screening

Did the subject complete the Screening period AND enter the treatment phase?
Descripción

Screening completed and enrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C4041024
If no, give primary reason
Descripción

Reason

Tipo de datos

text

Alias
UMLS CUI [1]
C0392360
If primary reason is "Screen failure" (not met inclusion criteria / met exclusion criteria) specify criterion
Descripción

Please specify

Tipo de datos

text

Alias
UMLS CUI [1]
C1521902
If primary reason is "Other", specify
Descripción

Please specify

Tipo de datos

text

Alias
UMLS CUI [1]
C1521902
Comment (if applicable)
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Radium 223 Dichloride (Alpharadin) - In- and Exclucsion criteria

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion criteria
Informed consent
Item
Was the signed informed consent (IC) obtained before any study specific procedure? Subjects must be able to understand and be willing to sign the written informed consent form (ICF). A signed ICF must be appropriately obtained prior to the conduct of the trial specific procedure.
boolean
C0021430 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Age and gender
Item
Is the subject a male patient and 18 years of age?
boolean
C0001779 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
Confirmed diagnosis
Item
Does the subject have histologically or cytologically confirmed prostate cancer?
boolean
C0011900 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Metastatic disease, progressive disease
Item
Is the subject diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)?
boolean
C0936223 (UMLS CUI [1,1])
C0677932 (UMLS CUI [1,2])
C0741600 (UMLS CUI [1,3])
Metastatic disease, progressive disease
Item
Is the subject diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)?
boolean
C0936223 (UMLS CUI [1,1])
C0677932 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Metastatic disease, progressive disease, metastasis documentation
Item
Is the subject diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)? A standart of practice bone scan for the documentation of at least two skeletal metastases can be used as long as it is within 3 months of planned start of treatment. If no bone scan within a 3 months window is available, then a technetium-99m bone scan will be obtained at screening (within 28 days of planned start of study drug).
boolean
C0936223 (UMLS CUI [1,1])
C0677932 (UMLS CUI [1,2])
C0741600 (UMLS CUI [1,3])
C0175636 (UMLS CUI [2,1])
C0303611 (UMLS CUI [2,2])
C0203668 (UMLS CUI [2,3])
Progressive disease , bone lesion, PSA
Item
Does the subject have progressive disease is defined either byThe appearance of new bone lesions. Ifprogression is based on new lesion(s) on bone scan only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; orln the absence ofnew bone lesions, by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA >= 5 ng/mL
boolean
C0677932 (UMLS CUI [1,1])
C0741600 (UMLS CUI [1,2])
C0238792 (UMLS CUI [1,3])
C0138741 (UMLS CUI [1,4])
Progressive disease , bone lesion, PSA
Item
Does the subject have progressive disease is defined either by the appearance of new bone lesions. Ifprogression is based on new lesion(s) on bone imaging only without an increase in PSA, PSA values from 3 assessments within the last 6 months must be provided; orln the absence ofnew bone lesions, by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA >= 5 ng/mL
boolean
C0677932 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0238792 (UMLS CUI [1,3])
C0138741 (UMLS CUI [1,4])
Life expectancy
Item
Does the subject have a life expectancy >= 6 months?
boolean
C0023671 (UMLS CUI [1])
ECOG performance
Item
Does the subject have an Eastem Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2?
boolean
C1520224 (UMLS CUI [1])
Laboratory parameter, hematology, liver and renal function
Item
Does the subject have adequate hematological, liver and renal function?absolute neutrophil count (ANC) >= 1.5 xl09/Lplatelet count >= 100 x 109/Lhemoglobin >= 10.0 g/dL (100 g/L; 6.2 mmol/L)total bilirubin level <= 1.5 x institutional upper limit of normal (ULN)aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<= 2.5 x ULNcreatinine <= 1.5 x ULNalbumin > 25 g/L
boolean
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0232804 (UMLS CUI [1,3])
C0232741 (UMLS CUI [1,4])
Compliance behavior
Item
Is the subject willing and able to comply with the protocol, including follow-up visits and examinations?
boolean
C1321605 (UMLS CUI [1])
Chemotherapy regimen
Item
Is the subject without intent to use cytotoxic chemotherapy within the next 6 months?
boolean
C0392920 (UMLS CUI [1,1])
C0162425 (UMLS CUI [1,2])
Item Group
Exclusion criteria
Study subject participation status
Item
Did the subject have any treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up?
boolean
C2348568 (UMLS CUI [1])
First line treatment eligibility
Item
Is the subject eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available?
boolean
C0013893 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
Chemotherapy regimen, adverse events
Item
Has the subject had treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)?
boolean
C0392920 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Chemotherapy regimen, adverse events
Item
Has the subject had treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks previous prior to screening (however ongoing neuropathy is permitted)?
text
C0392920 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Radiotherapy
Item
Has the subject received previous radiotherapy to approximately > 25percent of bone marrow, including hemibody radiation?
boolean
C1522449 (UMLS CUI [1])
hemibody external radiotherapy
Item
Has the subject had prior hemibody external radiotherapy? Patients who received other types of prior extemal radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for haemoglobin, absolute neutrophil count, and platelets.
boolean
C0419095 (UMLS CUI [1,1])
C0206113 (UMLS CUI [1,2])
Systemic therapy with radionuclides
Item
Has the subject received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 chloride) for the treatment of bony metastases?
boolean
C0203617 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Other malignant neoplasm
Item
Has the subject had other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)?
boolean
C0085183 (UMLS CUI [1])
Visceral metastases
Item
Does the subject have Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)?
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
Visceral metastases
Item
Does the subject have visceral metastases as assessed by abdominal or pelvic computed tomography (CT) ( or other imaging modality based on institutional standard ofcare)?
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
brain metastases
Item
Is there presence of brain metastases?
boolean
C0220650 (UMLS CUI [1])
lymphadenopathy
Item
Does the subject have lymphadenopathy exceeding 6 cm in short-axis diameter?
boolean
C0497156 (UMLS CUI [1])
pelvic lymphadenopathy, contributor to concurrent hydronephrosis
Item
Does the subject have any size pelvic lymphadenopathy thought to be a contributor to concurrent hydronephrosis?
boolean
C1264124 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0020295 (UMLS CUI [1,3])
spinal cord compression
Item
Does the subject have imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)? Patients with history of spinal cord compression should have completely recovered.
boolean
C0037926 (UMLS CUI [1])
Concomitant condition
Item
Does the subject have any other serious illness or medical condition, such as but not limited to::Any infection >= NCI-CTCAE v.4.03 Grade 2? Cardiac failure New York Heart Association (NYHA) Class III or IV? Crohn's disease or ulcerative colitis? Bone marrow dysplasia?
boolean
C0243086 (UMLS CUI [1])
fecal incontinence
Item
Does the subject have fecal incontinence?
boolean
C0015732 (UMLS CUI [1])
Concomitant agent
Item
Has the subject had treatment with any prior anticancer therapy (including, therapeutic vaccines), other than the permitted Standard of Care therapies (please refer to section 6.9)? The Standard of Care therapies are allowed provided that they are completed 28 days before treatment or 5.5 half-lives ofthe drugs involved have elapsed before treatment start.
boolean
C2347852 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Item Group
End of screening
Screening completed and enrolled
Item
Did the subject complete the Screening period AND enter the treatment phase?
boolean
C1710477 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C4041024 (UMLS CUI [2])
Reason
Item
If no, give primary reason
text
C0392360 (UMLS CUI [1])
Please specify
Item
If primary reason is "Screen failure" (not met inclusion criteria / met exclusion criteria) specify criterion
text
C1521902 (UMLS CUI [1])
Please specify
Item
If primary reason is "Other", specify
text
C1521902 (UMLS CUI [1])
Comment
Item
Comment (if applicable)
text
C0947611 (UMLS CUI [1])
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