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])
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])
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])