Age
Item
1. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy of ≥ 6 months
boolean
C0023671 (UMLS CUI [1])
Hormone refractory prostate cancer metastatic minimal symptomatic | Hormone refractory prostate cancer metastatic asymptomatic
Item
4. minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
boolean
C1328504 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0547040 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
C1328504 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
Adenocarcinoma of prostate
Item
1. histologically-confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Androgen suppression
Item
2. evidence of adequate androgen deprivation, as evidence by one of the following:
boolean
C1515985 (UMLS CUI [1])
Male Castration
Item
bilateral orchiectomy
boolean
C0007347 (UMLS CUI [1])
Luteinizing Hormone-releasing Hormone Agonist | Leuprolide | Goserelin
Item
ongoing lhrh agonist (e.g. leuprolide, goserelin) and serum testosterone <50 ng/dl
boolean
C1518041 (UMLS CUI [1])
C0085272 (UMLS CUI [2])
C0120107 (UMLS CUI [3])
Luteinizing hormone releasing hormone antagonist product | degarelix | Serum testosterone measurement
Item
ongoing lhrh antagonist (e.g. degarelix) and serum testosterone <50 ng/dl
boolean
C1276926 (UMLS CUI [1])
C1455035 (UMLS CUI [2])
C0428413 (UMLS CUI [3])
Hormone refractory prostate cancer
Item
3. evidence of prostate cancer resistance to castration, as evidenced by one of the following:
boolean
C1328504 (UMLS CUI [1])
Raised prostate specific antigen | PSA Level Nadir Antiandrogen therapy
Item
2 consecutive psa levels that are ≥ 50% above the psa nadir achieved on adt and obtained at least 1 week apart
boolean
C0178415 (UMLS CUI [1])
C4086720 (UMLS CUI [2,1])
C1708760 (UMLS CUI [2,2])
C0279492 (UMLS CUI [2,3])
Disease Progression Soft tissue CT | Disease Progression Soft tissue MRI | Disease Progression Lymph nodes CT | Disease Progression Lymph nodes MRI | Lesion New Quantity Bone scan
Item
ct or mri based evidence of disease progression (soft tissue or nodal) according to pcwg2 criteria or recist 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
boolean
C0242656 (UMLS CUI [1,1])
C0225317 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0225317 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4,1])
C0024204 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C0205314 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0203668 (UMLS CUI [5,4])
Neoplasm Metastasis Non-Visceral Imaging
Item
4. presence of non-visceral metastases on imaging
boolean
C0027627 (UMLS CUI [1,1])
C1518392 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Absence Symptoms Prostate carcinoma
Item
5. absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:
boolean
C0332197 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Exception | Ureteral obstruction Secondary to Pelvic lymphadenopathy | Ureteral obstruction Secondary to Retroperitoneal lymphadenopathy
Item
ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy
boolean
C1705847 (UMLS CUI [1])
C0041956 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C1264124 (UMLS CUI [2,3])
C0041956 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0748390 (UMLS CUI [3,3])
Exception | Bladder neck obstruction Secondary to Prostate cancer recurrent Locally
Item
bladder outlet obstruction secondary to locally recurrent prostate cancer
boolean
C1705847 (UMLS CUI [1])
C0005694 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0278838 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
Lymphadenopathy Radiography | Lymph node Diameter CT | Lymph node Diameter MRI | Lymph node Diameter PET/CT
Item
5. radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (ct or mri or pet/ct)
boolean
C0497156 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0024204 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0024204 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C1699633 (UMLS CUI [4,3])
Laboratory Parameters
Item
6. adequate laboratory parameters
boolean
C0022877 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
Major surgery Previous | Standard of Care Operative Surgical Procedures
Item
7. a minimum of 4 weeks from any major surgery prior to registration. coincident standard of care surgery with the research biopsy is permitted during the study.
boolean
C0679637 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
sipuleucel-T
Item
1. prior treatment with sipuleucel-t
boolean
C1706668 (UMLS CUI [1])
Hypersensitivity Sipuleucel-T Component
Item
2. allergy to any component of sipuleucel-t
boolean
C0020517 (UMLS CUI [1,1])
C1706668 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Leukapheresis Receive Unable
Item
3. inability to undergo leukapheresis
boolean
C0023416 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Prostate Neuroendocrine Neoplasm | Small cell carcinoma of prostate
Item
4. history of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
boolean
C1335515 (UMLS CUI [1])
C1300585 (UMLS CUI [2])
Extensive surgical procedure Biopsy Complex | Prior Extensive Radiation Biopsy Complex | Extensive surgical procedure High risk of Intraoperative injury | Prior Extensive Radiation High risk of Intraoperative injury
Item
5. extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
boolean
C4060998 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0439855 (UMLS CUI [1,3])
C1514458 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0439855 (UMLS CUI [2,3])
C4060998 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C1558210 (UMLS CUI [3,3])
C1514458 (UMLS CUI [4,1])
C0332167 (UMLS CUI [4,2])
C1558210 (UMLS CUI [4,3])
Chronic disease Requirement Adrenal Cortex Hormones Daily | Chronic disease Requirement Immunosuppressive Agents Daily
Item
6. any chronic medical condition requiring daily corticosteroids or other immunosuppressants
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
Solid organ transplant Requirement Therapeutic immunosuppression
Item
7. solid organ transplantation requiring immunosuppression
boolean
C0730400 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Neoplasm Metastasis Visceral | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver
Item
8. visceral (e.g. lung, liver) metastases
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0153676 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
9. known brain metastases
boolean
C0220650 (UMLS CUI [1])
Compression of spinal cord
Item
10. history of spinal cord compression
boolean
C0037926 (UMLS CUI [1])
Fractures of the long bones Untreated | Stabilization Lacking Fractures of the long bones
Item
11. untreated/unstabilized pathologic long bone fractures
boolean
C0240231 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1293130 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0240231 (UMLS CUI [2,3])
Cancer Other | Exception Skin carcinoma | Probability Percentage Recurrence
Item
12. other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0033204 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0034897 (UMLS CUI [3,3])
Investigational New Drugs
Item
13. administration of any investigational therapeutic within 30 days of registration
boolean
C0013230 (UMLS CUI [1])
Condition Study Subject Participation Status Excluded
Item
14. any condition which, in the opinion of the investigator, would preclude participation in this trial
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])