Gender | Age | Adenocarcinoma of the prostate metastatic Bone scan | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
1. males age ≥ 18 years with histologically confirmed adenocarcinoma of the prostate, which is now metastatic (e.g. any t, any n, m1a-c) based on bone scan, ct scan, or mri scan.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0862636 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
Disease Progression | Androgen suppression | Male Castration | Androgen Antagonists Withdrawal
Item
2. progression of disease despite androgen deprivation (androgen ablation or surgical castration) and anti-androgen withdrawal as documented by one or more of the following.
boolean
C0242656 (UMLS CUI [1])
C1515985 (UMLS CUI [2])
C0007347 (UMLS CUI [3])
C0002842 (UMLS CUI [4,1])
C2349954 (UMLS CUI [4,2])
Measurable Disease Progression
Item
progression of measurable disease per recist
boolean
C1513041 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Disease Progression Bone scan | Lesion New Quantity Bone scan | Prostate carcinoma
Item
bone scan progression, defined as the appearance of ≥ 2 new lesions on bone scan, attributable to prostate cancer
boolean
C0242656 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0203668 (UMLS CUI [2,4])
C0600139 (UMLS CUI [3])
Raised prostate specific antigen Assessment Quantity | Assessment Previous Reference
Item
rising psa, as defined by increasing levels on at least two consecutive assessments, following a prior assessment taken as a reference value, where all of the following are met:
boolean
C0178415 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1706462 (UMLS CUI [2,3])
Assessment Week Quantity Separate
Item
the assessments are at least one week apart, with the first assessment at least one week later than the reference value
boolean
C1516048 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0443299 (UMLS CUI [1,4])
Increase Progressive
Item
progressive increase in the two assessments after the reference value, without an intervening decrease between assessments.
boolean
C0442805 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Result Last
Item
the last value prior to study entry is ≥ 2 ng/ml
boolean
C1274040 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
Serum testosterone measurement Post Orchiectomy | Serum testosterone measurement while Androgen suppression | LHRH Agonist | LHRH antagonists
Item
3. serum testosterone level ≤ 50 ng/dl post orchiectomy or while maintained on continuous or intermittent medical androgen suppression with a lhrh agonist or antagonist.
boolean
C0428413 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0029189 (UMLS CUI [1,3])
C0428413 (UMLS CUI [2,1])
C0750519 (UMLS CUI [2,2])
C1515985 (UMLS CUI [2,3])
C1518041 (UMLS CUI [3])
C0023610 (UMLS CUI [4,1])
C0243076 (UMLS CUI [4,2])
Ketoconazole Discontinued | Systemic steroids Discontinued | Flutamide Discontinued | Megestrol Discontinued | Aminoglutethimide Discontinued | Bicalutamide Discontinued | Nilutamide Discontinued
Item
4. at least 2 weeks since ketoconazole or systemic steroids (any dose); 2 weeks since prior flutamide, megestrol, or aminoglutethimide; and at least 2 weeks since prior bicalutamide or nilutamide
boolean
C0022625 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0016384 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0025175 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0002555 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0285590 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0068771 (UMLS CUI [7,1])
C1444662 (UMLS CUI [7,2])
Therapeutic radiology procedure Completed | Samarium Treatment completed | Strontium Treatment completed | Prior Therapy Toxicity Patient recovered
Item
5. radiation therapy and/or therapy with samarium must have been completed 4 weeks prior to first dose of therapy. strontium therapy must have been completed at least 12 weeks prior to the first dose of therapy. the patient must have recovered from all treatment-related toxicities.
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0036147 (UMLS CUI [2,1])
C0580352 (UMLS CUI [2,2])
C0038467 (UMLS CUI [3,1])
C0580352 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0600688 (UMLS CUI [4,2])
C1115804 (UMLS CUI [4,3])
ECOG performance status
Item
6. ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Able to swallow Oral medication | Oral medication Retain Ability
Item
7. able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Chemotherapy Hormone refractory prostate cancer | Estramustine phosphate | Estracyt | Chemotherapy, Adjuvant | docetaxel | Disease Progression
Item
1. received prior chemotherapy (including estramustine phosphate [estracyt]) for hrpc. adjuvant chemotherapy (including docetaxel) is allowed provided that progression of disease occurred ≥ 6 months after the completion of adjuvant therapy.
boolean
C0392920 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
C0356799 (UMLS CUI [2])
C0014911 (UMLS CUI [3])
C0085533 (UMLS CUI [4])
C0246415 (UMLS CUI [5])
C0242656 (UMLS CUI [6])
Antiandrogen therapy hormonal Hormone refractory prostate cancer | LHRH | Testosterone level Male Castration Maintenance
Item
2. patients must not be receiving concurrent anti-androgen hormonal therapy for hrpc (lhrh directed therapies are acceptable to maintain castrate levels of testosterone).
boolean
C0279492 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C1328504 (UMLS CUI [1,3])
C0023610 (UMLS CUI [2])
C0428412 (UMLS CUI [3,1])
C0007347 (UMLS CUI [3,2])
C0024501 (UMLS CUI [3,3])
Monoclonal Antibodies | Antibody Targeting Vascular Endothelial Growth Factors | Prostate carcinoma Vaccine | Prior Therapy Toxicity resolved | Toxicity Grade
Item
3. treatment with monoclonal antibody (e.g., vegf targeting antibody) or prostate cancer vaccine within 45 days prior to the first dose of study treatment. acute toxicities from prior therapy must have resolved to grade ≤ 1.
boolean
C0003250 (UMLS CUI [1])
C0003241 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C1256770 (UMLS CUI [2,3])
C0600139 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1514463 (UMLS CUI [4,1])
C0600688 (UMLS CUI [4,2])
C1514893 (UMLS CUI [4,3])
C2826262 (UMLS CUI [5])
CNS metastases | Meningeal Carcinomatosis
Item
4. known history of or clinical evidence of central nervous system (cns) metastases or leptomeningeal carcinomatosis
boolean
C0686377 (UMLS CUI [1])
C0220654 (UMLS CUI [2])
Secondary Malignant Neoplasm | Malignant Neoplasms
Item
5. active secondary malignancy or history of other malignancy within the last 5 years
boolean
C3266877 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Therapeutic radiology procedure Bone Marrow Percentage
Item
6. prior history of radiation therapy to ≥ 30% of the bone marrow
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Peripheral Neuropathy CTCAE Grades
Item
7. peripheral neuropathy of ≥ grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Malabsorption Syndrome | Disease Affecting Gastrointestinal function | Stomach Excision | Small intestine excision | Ulcerative Colitis | Inflammatory Bowel Diseases | Partial obstruction of small bowel | Small bowel obstruction Complete
Item
8. patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded.
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
C1304699 (UMLS CUI [3])
C0192601 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
C0021390 (UMLS CUI [6])
C0281936 (UMLS CUI [7])
C0235329 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
Heart Disease New York Heart Association Classification
Item
9. class 3 or 4 cardiac disease as defined by the new york heart association functional classification
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Mycose Symptomatic | Bacterial Infection Symptomatic | Virus Disease Symptomatic | HIV Infection
Item
10. known active symptomatic fungal, bacterial and/or viral infection including active hiv. note: screening for viruses is not required.
boolean
C0026946 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0004623 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4])
Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
11. psychiatric illness/social situations that would limit compliance with the study requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])