Informed Consent
Item
1. written informed consent provided prior to initiation of study procedures
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate Biopsy of prostate | Specimen from prostate obtained by radical prostatectomy | Prostate carcinoma Histology Mixed | Neoplasm Percentage Adenocarcinoma
Item
3. histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. if prostatic tumor is of mixed histology, > 50% of the tumor must be adenocarcinoma
boolean
C0007112 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C1292667 (UMLS CUI [2])
C0600139 (UMLS CUI [3,1])
C0344441 (UMLS CUI [3,2])
C0205430 (UMLS CUI [3,3])
C0027651 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0001418 (UMLS CUI [4,3])
Secondary malignant neoplasm of bone | Lesion Quantity Bone scan
Item
4. bone metastases as manifested by one or more lesions on a bone scan performed within 2 months of screening
boolean
C0153690 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0203668 (UMLS CUI [2,3])
Hormone refractory prostate cancer | Castration Levels of Testosterone Testosterone measurement | Disease Progression | Male Castration | Antiandrogen therapy | Raised prostate specific antigen Quantity | Lesion New Bone scan
Item
5. castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (≤ 50 ng/dl), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (adt), as demonstrated by two consecutive rises in psa or new lesions on bone scan:
boolean
C1328504 (UMLS CUI [1])
C4289828 (UMLS CUI [2,1])
C0523912 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C0007347 (UMLS CUI [4])
C0279492 (UMLS CUI [5])
C0178415 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0221198 (UMLS CUI [7,1])
C0205314 (UMLS CUI [7,2])
C0203668 (UMLS CUI [7,3])
Raised prostate specific antigen Result Quantity
Item
psa progression will be defined as 2 rising psa values compared to a reference value, measured at least 7 days apart and the second value is ≥ 2 ng/ml [1]. it must be documented within 2 months of screening.
boolean
C0178415 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Abnormal results of radionuclide uptake studies Bone scan | Imaging studies During Castration | Imaging studies Before Castration | Lesion Pre-existing Bone scan
Item
appearance of one or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response. increased uptake of pre-existing lesions on bone scan does not constitute progression. it must be documented within 4 months of screening
boolean
C4290294 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C1881134 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0007344 (UMLS CUI [2,3])
C1881134 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0007344 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C2347662 (UMLS CUI [4,2])
C0203668 (UMLS CUI [4,3])
Prostate specific antigen measurement
Item
6. serum psa ≥ 2.0 ng/ml
boolean
C0201544 (UMLS CUI [1])
ECOG performance status
Item
7. screening ecog perf status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Asymptomatic Diseases | Disease Minimal Symptomatic | Narcotic Analgesics Absent | Analgesics
Item
8. asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
boolean
C2936329 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C0027409 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0002771 (UMLS CUI [4])
abiraterone | enzalutamide
Item
9. prior abiraterone and enzalutamide are permitted, but not required
boolean
C0754011 (UMLS CUI [1])
C3496793 (UMLS CUI [2])
Osteoclast inhibitors Dose Stable | zoledronic acid | denosumab
Item
10. concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month
boolean
C3161558 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0257685 (UMLS CUI [2])
C1690432 (UMLS CUI [3])
Hematologic function Laboratory test result | Renal function Laboratory test result | Liver function Laboratory test result
Item
11. adequate screening hematologic, renal, and liver function as evidenced by laboratory test results within the following ranges ≤ 28 days prior to registration:
boolean
C0221130 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0587081 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0587081 (UMLS CUI [3,2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥ 1.5 x109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 10.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin level ≤ 1.5 x institutional upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine ≤ 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Albumin measurement
Item
albumin > 25 g/l
boolean
C0201838 (UMLS CUI [1])
Secondary malignant neoplasm of lung Diameter Long axis | Secondary malignant neoplasm of liver Diameter Long axis
Item
1. the presence of known lung or liver metastases greater than 1.0 cm in the long axis diameter
boolean
C0153676 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0522487 (UMLS CUI [1,3])
C0494165 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0522487 (UMLS CUI [2,3])
Lymphadenopathy Diameter Short axis
Item
2. the presence of lymphadenopathy greater than 3 cm in the short-axis diameter
boolean
C0497156 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0522488 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain
Item
3. the presence of known brain metastases
boolean
C0220650 (UMLS CUI [1])
Compression of spinal cord | Fractures of the long bones Impending | Condition Requirement Therapeutic radiology procedure | Requirement Steroids Pain control
Item
4. spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase
boolean
C0037926 (UMLS CUI [1])
C0240231 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C1304888 (UMLS CUI [4,3])
Chemotherapy Castration-Resistant Prostatic Cancer metastatic | Chemotherapy, Adjuvant | Chemotherapy
Item
5. previous treatment with chemotherapy for mcrpc (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration
boolean
C0392920 (UMLS CUI [1,1])
C3658266 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
C0085533 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
Chemotherapy intended
Item
6. intention to receive chemotherapy within 6 months after enrollment in protocol therapy
boolean
C3665472 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Therapeutic radiology procedure | Teleradiotherapy procedure | Brachytherapy
Item
7. history of radiation therapy, either via external beam or brachytherapy within 28 days prior to registration
boolean
C1522449 (UMLS CUI [1])
C0419095 (UMLS CUI [2])
C0006098 (UMLS CUI [3])
Systemic Radiation Therapy Secondary malignant neoplasm of bone | Strontium-89 | Samarium 153 | Rhenium-186 | Rhenium-188
Item
8. systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
boolean
C2985381 (UMLS CUI [1,1])
C0153690 (UMLS CUI [1,2])
C0281385 (UMLS CUI [2])
C0677942 (UMLS CUI [3])
C0361302 (UMLS CUI [4])
C1828331 (UMLS CUI [5])
Cancer Other | Exception Skin carcinoma | Exception Transitional Cell Carcinoma low grade
Item
9. prior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007138 (UMLS CUI [3,2])
C1282907 (UMLS CUI [3,3])
Prednisone | Systemic Corticosteroid Equivalent
Item
10. use of prednisone or equivalent systemic corticosteroid within 2 weeks of treatment. use of inhaled, intranasal, intra-articular, and topical steroids is allowed. oral or iv steroids to prevent or treat iv contrast reactions are allowed
boolean
C0032952 (UMLS CUI [1])
C4053960 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Opioid Analgesics Cancer Pain
Item
11. use of opioid analgesics for cancer-related pain
boolean
C0002772 (UMLS CUI [1,1])
C0596240 (UMLS CUI [1,2])
Investigational New Drugs
Item
12. use of experimental drug within 4 weeks of treatment
boolean
C0013230 (UMLS CUI [1])
Medical condition Uncontrolled | Diabetes Mellitus | Heart failure | Chronic Obstructive Airway Disease | Ulcerative Colitis | Crohn Disease
Item
13. uncontrolled medical conditions including diabetes, heart failure, copd, ulcerative colitis, or crohn's disease
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
C0010346 (UMLS CUI [6])
Fecal Incontinence Uncontrolled
Item
14. uncontrolled fecal incontinence
boolean
C0015732 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Intervention compromises Protocol Compliance | Intervention compromises Clinical Trial | Condition compromises Protocol Compliance | Condition compromises Clinical Trial | Circumstances compromise Protocol Compliance | Circumstances compromise Clinical Trial
Item
15. any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives
boolean
C0184661 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0008976 (UMLS CUI [4,3])
C0680082 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0680082 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C0008976 (UMLS CUI [6,3])