Gender | Age
Item
1. males ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
2. histological diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Distant metastasis
Item
3. documented evidence of distant metastasis of disease
boolean
C1269798 (UMLS CUI [1])
Chemotherapy Quantity CRPC | Biological treatment Quantity CRPC | Combined Modality Therapy Quantity CRPC | Vitamin D Analog Quantity CRPC | Prior Therapy | Toxicity Patient recovered
Item
4. no more than 1 prior chemotherapeutic, biologic or combination treatment regimen (including vitamin d analogues) for crpc. if previously treated, patients must be recovered from all toxicities prior to entry into the study.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1328504 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1328504 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1328504 (UMLS CUI [3,3])
C2917444 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1328504 (UMLS CUI [4,3])
C1514463 (UMLS CUI [5])
C0600688 (UMLS CUI [6,1])
C1115804 (UMLS CUI [6,2])
Disease Progression | Male Castration | Orchiectomy | Medical Castration | LHRH Analogue | Androgen Antagonists Withdrawal | Flutamide | nilutamide | bicalutamide
Item
5. patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (lhrh analogue); anti-androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on antiandrogens and a duration of response to antiandrogens > 3months;
boolean
C0242656 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0029189 (UMLS CUI [3])
C1513054 (UMLS CUI [4])
C1518041 (UMLS CUI [5])
C0002842 (UMLS CUI [6,1])
C2349954 (UMLS CUI [6,2])
C0016384 (UMLS CUI [7])
C0068771 (UMLS CUI [8])
C0285590 (UMLS CUI [9])
Testosterone measurement Medical Castration | Testosterone measurement Male Castration | Medical Castration Continue
Item
6. testosterone < 50 ng/dl achieved via medical or surgical castration. patients receiving medical castration therapy must continue such therapy throughout the study.
boolean
C0523912 (UMLS CUI [1,1])
C1513054 (UMLS CUI [1,2])
C0523912 (UMLS CUI [2,1])
C0007347 (UMLS CUI [2,2])
C1513054 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
Hematologic function | Renal function | Liver function
Item
7. adequate hematologic, renal and liver function:
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Serology negative HIV-1 | Serology negative HIV-2 | Serology negative Human T-lymphotropic virus 1 | Serology negative Hepatitis B Surface Antigens | Serology negative Hepatitis C virus
Item
8. negative serology tests for human immunodeficiency virus (hiv-1 and 2), human t-cell lymphotropic virus (htlv-1), hepatitis b surface antigen (hbsag) and hepatitis c (hcv)
boolean
C0919674 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0919674 (UMLS CUI [2,1])
C0019707 (UMLS CUI [2,2])
C0919674 (UMLS CUI [3,1])
C0020094 (UMLS CUI [3,2])
C0919674 (UMLS CUI [4,1])
C0019168 (UMLS CUI [4,2])
C0919674 (UMLS CUI [5,1])
C0220847 (UMLS CUI [5,2])
Karnofsky Performance Status
Item
9. karnofsky performance score (kps) ≥ 70%
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
10. life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
11. written informed consent obtained prior to the initiation of study procedures
boolean
C0021430 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Pleural effusion | Ascites
Item
1. the presence of brain metastases, pleural effusions or ascites
boolean
C0220650 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
Fractures of the long bones | Fractures of the long bones Expected | Cortical bone erosion Percentage Radiography | Compression of spinal cord
Item
2. pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%), or spinal cord compression
boolean
C0240231 (UMLS CUI [1])
C0240231 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C0948713 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
C0037926 (UMLS CUI [4])
Malignant Neoplasms TNM clinical staging | Exception Prostate carcinoma | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Disease Free of | Malignant Neoplasms TNM clinical staging Treated
Item
3. a history of stage iii or greater cancer, excluding prostate cancer. basal or squamous cell skin cancers must have been adequately treated and the patient must be disease-free at the time of registration. patients with a history of stage i or ii other cancers must have been adequately treated and been disease-free for 3 years at the time of registration.
boolean
C0006826 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6,1])
C3258246 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
Chemotherapy Quantity CRPC | Biological treatment Quantity CRPC | Combined Modality Therapy Quantity CRPC | Vitamin D Analog Quantity CRPC
Item
4. more than 1 prior chemotherapy, biologic or combination treatment regimen (including vitamin d analogues) for crpc
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1328504 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1328504 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1328504 (UMLS CUI [3,3])
C2917444 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1328504 (UMLS CUI [4,3])
Radiopharmaceuticals | Strontium-89 | Samarium-153
Item
5. any treatment with radiopharmaceuticals, e.g. strontium-89 and samarium-153
boolean
C0182638 (UMLS CUI [1])
C0281385 (UMLS CUI [2])
C0677942 (UMLS CUI [3])
Ketoconazole | Androgen Antagonists | Flutamide | nilutamide | bicalutamide | Androgen Antagonists Withdrawal Response | PSA decreased Percentage
Item
6. ketoconazole or antiandrogens (flutamide, nilutamide, bicalutamide) within 2 weeks prior to registration. patients who demonstrate an anti-androgen withdrawal response, defined as a > 25% drop in psa within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non-steroidal anti-androgen, are not eligible until the psa rises above the nadir observed after anti-androgen withdrawal.
boolean
C0022625 (UMLS CUI [1])
C0002842 (UMLS CUI [2])
C0016384 (UMLS CUI [3])
C0068771 (UMLS CUI [4])
C0285590 (UMLS CUI [5])
C0002842 (UMLS CUI [6,1])
C2349954 (UMLS CUI [6,2])
C0871261 (UMLS CUI [6,3])
C0178414 (UMLS CUI [7,1])
C0439165 (UMLS CUI [7,2])
Diphosphonates Dose unchanged
Item
7. initiation of bisphosphonate therapy within 28 days prior to registration. patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted.
boolean
C0012544 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Systemic steroids Patient need for | Therapeutic immunosuppression Patient need for
Item
8. a requirement for systemic steroid or other immunosuppressive therapy for any reason.
boolean
C2825233 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Pharmaceutical Preparations | Intervention
Item
9. treatment with any of the following medications or interventions < 28 days prior to screening
boolean
C0013227 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
Vaccines Investigational | Investigational New Drugs
Item
10. treatment with any investigational vaccine within 2 years prior to screening, or treatment with any other investigational product within 28 days prior to screening
boolean
C0042210 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Antibiotic therapy | Communicable Disease | Unexplained fever
Item
11. any antibiotic therapy or infection within 1 week prior to screening, including unexplained fever (temperature ≥ 100.5f or 38.1c)
boolean
C0338237 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C1844662 (UMLS CUI [3])
Autoimmune Diseases
Item
12. history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Chronic disease Serious | Illness Serious
Item
13. serious ongoing chronic or acute illness
boolean
C0008679 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Intervention compromises Protocol Compliance | Condition compromises Protocol Compliance
Item
14. any medical intervention or other condition which, in the opinion of the principal investigator and/or the bellicum medical monitor, could compromise adherence with study requirements
boolean
C0184661 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Criteria Additional
Item
other criteria apply however are not listed
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])