Age
Item
1. age over 18 years
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
2. histologically documented adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Secondary malignant neoplasm of prostate Progressive
Item
3. progressive metastatic prostate cancer
boolean
C0347001 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Testosterone Castration Level Maintenance
Item
4. castrate levels of testosterone (<50 ng/ml) must be maintained
boolean
C0039601 (UMLS CUI [1,1])
C0007347 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
C0024501 (UMLS CUI [1,4])
Hormone Therapy | Hormone preparation
Item
5. prior hormonal therapy or medications :
boolean
C0279025 (UMLS CUI [1])
C0019932 (UMLS CUI [2])
Antiandrogen therapy | Hormone Therapy Secondary | Ketoconazole | Aminoglutethimide | Megestrol Acetate | Diethylstilbestrol | 5-alpha Reductase Inhibitors | Finasteride | Proscar | Dutasteride | Avodart | Plant Preparations Prostate | Saw palmetto | PC-SPES | Pharmaceutical Preparations To be stopped
Item
patients who are receiving an anti-androgen, secondary hormonal therapy (i.e. ketoconazole, aminoglutethimide, megestrol acetate, diethylstilbestrol), 5-alpha reductase inhibitor (i.e. finasteride (proscar), dutasteride (avodart)) or herbal prostate medication (i.e. saw palmetto, pc-spes, pc-plus) must discontinue the drug by the date of initiation of chemotherapy on study
boolean
C0279492 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0022625 (UMLS CUI [3])
C0002555 (UMLS CUI [4])
C0065879 (UMLS CUI [5])
C0012203 (UMLS CUI [6])
C2936788 (UMLS CUI [7])
C0060389 (UMLS CUI [8])
C0678149 (UMLS CUI [9])
C0754659 (UMLS CUI [10])
C1170079 (UMLS CUI [11])
C0949854 (UMLS CUI [12,1])
C0033572 (UMLS CUI [12,2])
C0771607 (UMLS CUI [13])
C0756934 (UMLS CUI [14])
C0013227 (UMLS CUI [15,1])
C1272691 (UMLS CUI [15,2])
Major surgery | Fully recovered
Item
6. ≥ 4 weeks since major surgery and fully recovered
boolean
C0679637 (UMLS CUI [1])
C2826210 (UMLS CUI [2])
Toxicity Due to Therapeutic radiology procedure | Patient condition resolved Toxicity Grade
Item
7. ≥ 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to ≤grade 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C0438113 (UMLS CUI [2,1])
C2826262 (UMLS CUI [2,2])
Strontium | Samarium
Item
8. ≥ 8 weeks since the last dose of strontium or samarium
boolean
C0038467 (UMLS CUI [1])
C0036147 (UMLS CUI [2])
Patients Sexually active Contraceptive methods
Item
9. sexually active patients must agree to use adequate contraception
boolean
C0030705 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
10. karnofsky performance status ≥ 60%
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
11. life expectancy >12 weeks
boolean
C0023671 (UMLS CUI [1])
Laboratory Results Initial Required | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Serum total bilirubin measurement
Item
12. required initial laboratory values absolute neutrophil count > 1500/ul platelets > 100,000/ul hemoglobin > 8.0 g/dl creatinine ≤ 2.0 x upper limit of normal bilirubin ≤upper limit of normal (uln)
boolean
C1254595 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
ast/alt/alkaline phosphatase:
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
AST level normal | Alanine aminotransferase normal | Serum alkaline phosphatase normal | Alkaline phosphatase abnormal Due to Liver Dysfunction | Involvement with Secondary malignant neoplasm of bone Absent | Gamma-glutamyl transferase raised | Secondary malignant neoplasm of liver
Item
ast and alt and alkaline phosphatase must be within the range allowing for eligibility in determining eligibility, the more abnormal of the 2 values (ast or alt should be used. an abnormal alkaline phosphatase must be attributed to liver dysfunction and not metastatic bone involvement (i.e elevated ggtp or evidence of liver metastases)
boolean
C0580474 (UMLS CUI [1])
C0855620 (UMLS CUI [2])
C0428334 (UMLS CUI [3])
C0740888 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0086565 (UMLS CUI [4,3])
C1314939 (UMLS CUI [5,1])
C0153690 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0151662 (UMLS CUI [6])
C0494165 (UMLS CUI [7])
Inclusion criteria Enrollment Late
Item
inclusion criteria for late enrolling patients:
boolean
C1512693 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0205087 (UMLS CUI [1,3])
Age
Item
1. age over 18 years
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
2. histologically documented adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Docetaxel | Chemotherapy cycle Quantity Neoplasm Metastasis
Item
3. ≤3 cycles of prior docetaxel chemotherapy for metastatic disease permitted prior to enrollment
boolean
C0246415 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Docetaxel | Drug Administration Schedule Frequency
Item
4. docetaxel must have been administered on an every 3 week schedule
boolean
C0246415 (UMLS CUI [1])
C0013154 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
Docetaxel Dose
Item
5. each docetaxel dose must have been between 60 and 75 mg/m2
boolean
C0246415 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Testosterone Castration Level
Item
6. castrate levels of testosterone <50 ng/ml
boolean
C0039601 (UMLS CUI [1,1])
C0007347 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
Steroids Daily | Hydrocortisone | Dexamethasone | Prednisone | Steroids Absent
Item
7. daily use of other steroids (hydrocortisone, dexamethasone) instead of prednisone or no steroids, is permitted up until time of enrollment
boolean
C0038317 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0020268 (UMLS CUI [2])
C0011777 (UMLS CUI [3])
C0032952 (UMLS CUI [4])
C0038317 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
PSA Level | Docetaxel
Item
8. a psa level must have been documented within 6 weeks of initiating docetaxel chemotherapy
boolean
C4086720 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
Systemic Chemotherapy Prostate carcinoma | Exception Docetaxel | Exception Prednisone | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Recurrent disease Absent
Item
1. prior systemic chemotherapy for prostate cancer, other than q 3-week docetaxel/prednisone. prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy.
boolean
C1883256 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0032952 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C0085533 (UMLS CUI [5])
C0277556 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Docetaxel | Prednisone | Chemotherapy cycle Quantity
Item
2. >3 cycles of q3 week docetaxel/prednisone chemotherapy has already been administered to the patient
boolean
C0246415 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Peripheral Neuropathy CTCAE Grades
Item
3. peripheral neuropathy >grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Immunotherapy | GM-CSF Systemic | Vaccines Using GM-CSF | G-CSF Support | Neutropenia Chemotherapy Related
Item
4. prior immunotherapy including systemic gm-csf or vaccines utilizing gm-csf; prior g-csf support of chemotherapy-related neutropenia is permitted
boolean
C0021083 (UMLS CUI [1])
C0079460 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0042210 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0079460 (UMLS CUI [3,3])
C0079459 (UMLS CUI [4,1])
C1521721 (UMLS CUI [4,2])
C0027947 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
Biological agents | Angiogenesis Inhibitors | EGFR Antibody
Item
5. prior biologic agents (i.e.,anti-angiogenic agents, anti-egfr inhibitors)≤ 4 weeks prior to registration
boolean
C0005515 (UMLS CUI [1])
C0596087 (UMLS CUI [2])
C4055105 (UMLS CUI [3])
Investigational New Drugs Quantity
Item
6. more than two prior therapies with an investigational agent, completed ≤ 4 weeks prior to enrollment (no prior immunotherapeutics are allowed)
boolean
C0013230 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled
Item
7. myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (nyha class iii or higher) or uncontrolled cardiac arrhythmia
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0742758 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
HIV Seropositivity | Antiretroviral therapy Combined | Therapeutic Bone Marrow Suppression At risk Communicable Disease Lethal
Item
8. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, hiv-positive patients receiving combination anti-retroviral therapy are excluded
boolean
C0019699 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C2698538 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
C3151529 (UMLS CUI [3,4])
Severe allergy Docetaxel | Severe allergy Polysorbate 80 Drug Formulation
Item
9. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C0524527 (UMLS CUI [2,3])
Diabetes mellitus poor control | Fasting blood glucose measurement | Therapeutic procedure Optimal
Item
10. poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy
boolean
C0860161 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
Exclusion Criteria Enrollment Late
Item
exclusion criteria for late enrolling patients:
boolean
C0680251 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0205087 (UMLS CUI [1,3])
Immunotherapy | GM-CSF Systemic | Vaccines Using GM-CSF | G-CSF Support | Neutropenia Chemotherapy Related
Item
1. prior immunotherapy including systemic gm-csf or vaccines utilizing gm-csf; prior g-csf support for chemotherapy-related neutropenia is permitted
boolean
C0021083 (UMLS CUI [1])
C0079460 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0042210 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0079460 (UMLS CUI [3,3])
C0079459 (UMLS CUI [4,1])
C1521721 (UMLS CUI [4,2])
C0027947 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
Chemotherapy cycle Quantity | Interval Delay
Item
2. delay of ≥6 weeks between any 2 chemotherapy cycles prior to enrollment on study
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1272706 (UMLS CUI [2,1])
C0205421 (UMLS CUI [2,2])
Chemotherapy cycles | Interval Delay Cumulative
Item
3. cumulative delays ≥8 weeks between chemotherapy cycles prior to enrollment on study
boolean
C1302181 (UMLS CUI [1])
C1272706 (UMLS CUI [2,1])
C0205421 (UMLS CUI [2,2])
C1511559 (UMLS CUI [2,3])