Eligibility Prostate Cancer NCT01262664

1 moduli

StudyEvent: Eligibility
1. Eligibility Prostate Cancer NCT01262664

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

prostata carcinoma; bmi

Item

1. have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a bmi defined as obese (i.e. >30 kg/m2). any histologic variant is acceptable other than small cell carcinoma.

boolean

C0600139 (UMLS CUI [1])
C1305855 (UMLS CUI [2])

therapy androgen; testosterone

Item

2. have been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trial.

boolean

C0087111 (UMLS CUI [1,1])
C0002844 (UMLS CUI [1,2])
C0039601 (UMLS CUI [2])

ketoconazole; abiraterone; Dexamethasone

Item

3. patients with castrate resistant prostate cancer (crpc) must have no standard options for therapy. prior to registration on the study, patients with crpc must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial).

boolean

C0022625 (UMLS CUI [1])
C0754011 (UMLS CUI [2])
C0011777 (UMLS CUI [3])

ecog

Item

4. have an ecog performance status 0, 1 or 2

boolean

C1520224 (UMLS CUI [1])

bone marrow function; Granulocyte count; platelet count; hemoglobin

Item

5. have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dl (without transfusion or growth factor support)

boolean

C0412480 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])

hepatic function; total bilirubin; Aspartate aminotransferase measurement

Item

6. have adequate hepatic function defined as a total bilirubin of </= 1.5 mg/dl and ast </= 2x the upper limits of normal

boolean

C0232741 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])

renal function; serum creatinine; creatinine clearance

Item

7. have adequate renal function defined as serum creatinine </= 1.5x the upper limit of normal or creatinine clearance >/= 60 ml/min (measured or calculated). in addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. exception: patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting.

boolean

C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])

cardiovascular function; bnp; ecg

Item

8. have adequate cardiovascular function as defined by: i) a normal b-type natruetic peptide (bnp) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ecg. if these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (muga) showing an ef of 45% or greater with no more than "mild" diastolic dysfunction and a bnp of < 200 pg/ml to be eligible.

boolean

C0578149 (UMLS CUI [1])
C1095989 (UMLS CUI [2])
C0013798 (UMLS CUI [3])

informed consent

Item

9. sign the current irb approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Prostate carcinoma

Item

1. small cell prostate cancer

boolean

C0600139 (UMLS CUI [1])

Compliance behavior Limited Comorbidity; infection

Item

2. infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy

boolean

C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C3714514 (UMLS CUI [2])

nyha class; congestive heart failure; unstable angina; transient ischemic attack; pulmonary embolism

Item

3. any of the following in previous 6 months: nyha class iii/iv congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ecg or serologic criteria)

boolean

C1275491 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
C0034065 (UMLS CUI [5])

Compliance behavior Limited Comorbidity

Item

4. significant co-morbidity that could affect the safety or evaluability of participants, specifically including: i) chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. note that this may be better established with home bp readings than with clinic visit results. note further that this is not a criterion related to particular bp results at the time of assessment for eligibility, nor does it apply to acute bp excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. the intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, not to exclude patients who may be hypertensive acutely. there are no absolute criteria for bp readings with respect to eligibility (as determined by treating physician).

boolean

C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

diabetes mellitus; hiv infection; psychosis

Item

5. ( # 9 cont'd) (ii) uncontrolled diabetes mellitus, defined as: hgb a1c >8.5%; or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to >300 mg/dl in prior two months--unless clearly iatrogenic and the cause has been eliminated iii) lung disease requiring supplemental oxygen iv) known chronic liver disease causing either fibrosis or synthetic dysfunction v) known hiv infection vi) overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care.

boolean

C0011849 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0033975 (UMLS CUI [3])

hydronephrosis

Item

6. hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. exception: non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility.

boolean

C0020295 (UMLS CUI [1])

nsaid vancomycin aminoglycosides

Item

7. patients require ongoing therapy with non-steroidal anti-inflammatory drugs (nsaids), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from nsaids from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less).

boolean

C0003211 (UMLS CUI [1,1])
C0042313 (UMLS CUI [1,2])
C0002556 (UMLS CUI [1,3])

Compliance behavior Limited Comorbidity

Item

8. any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug.

boolean

C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

Contraception status

Item

9. unwillingness to maintain adequate contraception measures for the entire course of the study

boolean

C0420837 (UMLS CUI [1])

age

Item

10. age < 18 years.

boolean

C0001779 (UMLS CUI [1])

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Eligibility Prostate Cancer NCT01262664