Englisch

Eligibility Criteria

5 Formulare  
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
    3. Subject ID, sample ID, sample source, source sample ID, and sample use variable obtained from Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
    4. Subject ID, age, race, composite endpoint for progression after 12 weeks of abiraterone acetate chemotherapy, and sex of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
    5. Sample ID, body site where sample was obtained, analyte type, primary or metastatic tumor, primary tumor location, tumor stage, tumor treatment, treatment post visit, histological type, sequence center, and body site category where sample was collected [bone or tissue] of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
Inclusion and exclusion criteria
Beschreibung

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Inclusion Criteria 3.11 Males age ≥ 18 years. 3.12 Histological diagnosis of adenocarcinoma of the prostate or documented history in medical records of having received treatment for prostate cancer diagnosis. 3.13 Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan amenable to biopsy. 3.14 The following laboratory values obtained ≤14 days prior to registration a. Hematology: HgB >9.0 gm, ANC ≥ 1500 cells /L, and platelets ≥100,000μ/L b. Creatinine ≤ 1.5 x upper limit of normal (ULN). c. SGOT (AST) and SGPT (ALT) ≤ 1.5 x ULN. d. Castrate serum testosterone level (< 50 ng/dL-or-< 1.7 nmol/L). 3.15 Progression while on or after androgen deprivation therapy defined as: a. Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed or the appearance of one or more new lesions as assessed by imaging during hormone ablation treatment. Measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions ≥ 20 mm in diameter or visceral/soft-tissue lesions ≥ 10 mm in diameter (see Section 11.0). OR b. Bone Scan Progression: appearance of 2 or more new lesions on bone scan during hormone ablation treatment. OR c. Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 2.0 ng/mL is required for study enrollment. NOTE: Androgen deprivation therapy may have included either medical or surgical castration. 3.16 ≥14 days has passed since completing radiotherapy (exception for radiotherapy: ≥ 7 days since completing a single fraction of ≤ 800 cGy to 14 MC1351 Template revised: 1/30/2012 a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration. 3.17 Patients who may have received systemic chemotherapy or any novel therapeutic CYP-17 inhibitor and/or novel AR inhibitor agents previously for prostate cancer should have received the last dose of the previously administered systemic therapy ≥12 months from the date of registration. 3.18 Provide informed written consent. 3.19a Has recovered from any other therapy-related toxicity to ≤ grade 2, (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy). 3.19b Willing to provide tissue and blood samples for correlative research purposes (see Section 6.2, 14.1, and 17.1 of the protocol) 3.19c ECOG Performance Status (PS) 0, 1 or 2 (Appendix I). 3.19d Patient is considered a candidate for initiating CYP-17 inhibitors Abiraterone acetate and prednisone after failure of hormonal therapy and has no contra-indication to starting this combination as standard of care. 3.19e Patients have stopped any antiandrogen therapy (including bicalutamide) ≥4 weeks prior to first dose of study drug. In addition any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5-alpha reductase inhibitors (eg, finasteride or dutasteride), must be discontinued ≥2 weeks before the first dose of study drug. 3.2 Exclusion Criteria 3.21 Use of any of the standard therapies for CRPC stage ≤12 months prior to registration. a. Initiation of full dose chemotherapy with Docetaxel for CRPC stage ≤12 months prior to registration is an exclusion criterion. Note: Docetaxel for hormone sensitive prostate cancer is not an exclusion criterion. b. Use of Radium-223 for CRPC stage is an exclusion criteria. c. Use of Provenge vaccine for CRPC ≤12 months prior to registration is an exclusion criterion. Note: Less than 3 doses of Provenge vaccine ≤12 months prior to registration for CRPC is not an exclusion criterion. 15 MC1351 Template revised: 1/30/2012. d. Initiation of full dose chemotherapy with Mitoxantrone for CRPC stage with-in the previous 12 months is an exclusion criterion. e. Use of Cabazitaxel chemotherapy ≤12 months prior to registration is an exclusion criterion Note: Initiation of full dose chemotherapy with cabazitaxel for CRPC stage with-in the previous 12 months is an exclusion criterion. f. Use of Ketoconazole with steroids ≤12 months prior to registration for CRPC stage Note: Ketoconazole therapy taken for a time period of ≤12 weeks in the 12 month period prior to registration is not an exclusion criterion. g. Use of Enzalutamide for CRPC stage ≤12 months prior to registration is an exclusion criteria Use of any experimental or standard of care CYP-17 inhibitors ≤12 months prior to registration is an exclusion criteria.
Beschreibung

Elig.phs001141.v1.p1.1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [2,1]
C0001779
UMLS CUI [3,1]
C0679557
UMLS CUI [3,2]
C0007112
UMLS CUI [3,3]
C0025102
UMLS CUI [3,4]
C0087111
UMLS CUI [3,5]
C0600139
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0817096
UMLS CUI [4,3]
C0000726
UMLS CUI [4,4]
C0030797
UMLS CUI [4,5]
C0040405
UMLS CUI [4,6]
C0203668
UMLS CUI [4,7]
C0005558
UMLS CUI [5,1]
C1254595
UMLS CUI [5,2]
C0332152
UMLS CUI [5,3]
C1514821
UMLS CUI [5,4]
C0019046
UMLS CUI [5,5]
C0948762
UMLS CUI [5,6]
C0032181
UMLS CUI [5,7]
C0201976
UMLS CUI [5,8]
C0201899
UMLS CUI [5,9]
C0201836
UMLS CUI [5,10]
C1319065
UMLS CUI [5,11]
C0428413
UMLS CUI [6,1]
C1335499
UMLS CUI [6,2]
C0279492
UMLS CUI [6,3]
C1704788
UMLS CUI [7,1]
C1335499
UMLS CUI [7,2]
C1704788
UMLS CUI [7,3]
C0205217
UMLS CUI [7,4]
C0221198
UMLS CUI [7,5]
C1301886
UMLS CUI [7,6]
C1522425
UMLS CUI [7,7]
C0700364
UMLS CUI [7,8]
C0205314
UMLS CUI [7,9]
C0221198
UMLS CUI [7,10]
C1516048
UMLS CUI [7,11]
C0011923
UMLS CUI [7,12]
C0347984
UMLS CUI [7,13]
C0279492
UMLS CUI [8,1]
C1335499
UMLS CUI [8,2]
C1704788
UMLS CUI [8,3]
C0203668
UMLS CUI [8,4]
C0700364
UMLS CUI [8,5]
C0205314
UMLS CUI [8,6]
C0221198
UMLS CUI [8,7]
C0347984
UMLS CUI [8,8]
C0279492
UMLS CUI [9,1]
C1335499
UMLS CUI [9,2]
C1704788
UMLS CUI [9,3]
C0205217
UMLS CUI [9,4]
C0201544
UMLS CUI [9,5]
C1524031
UMLS CUI [9,6]
C0442719
UMLS CUI [9,7]
C1514873
UMLS CUI [9,8]
C1516879
UMLS CUI [10,1]
C0279492
UMLS CUI [10,2]
C1513054
UMLS CUI [10,3]
C0007347
UMLS CUI [10,4]
C0543467
UMLS CUI [11,1]
C0449238
UMLS CUI [11,2]
C1711239
UMLS CUI [11,3]
C0205197
UMLS CUI [11,4]
C1522449
UMLS CUI [11,5]
C2348792
UMLS CUI [11,6]
C1514821
UMLS CUI [12,1]
C0205156
UMLS CUI [12,2]
C1883256
UMLS CUI [12,3]
C0087111
UMLS CUI [12,4]
C3846158
UMLS CUI [12,5]
C0600139
UMLS CUI [12,6]
C1762893
UMLS CUI [12,7]
C0449238
UMLS CUI [12,8]
C0332152
UMLS CUI [12,9]
C0011008
UMLS CUI [12,10]
C1514821
UMLS CUI [13,1]
C0021430
UMLS CUI [14,1]
C1115804
UMLS CUI [14,2]
C0600688
UMLS CUI [14,3]
C0678226
UMLS CUI [14,4]
C1514463
UMLS CUI [14,5]
C1705847
UMLS CUI [14,6]
C0002871
UMLS CUI [14,7]
C0002170
UMLS CUI [14,8]
C0037088
UMLS CUI [14,9]
C0279492
UMLS CUI [15,1]
C0600109
UMLS CUI [15,2]
C1999230
UMLS CUI [15,3]
C0040300
UMLS CUI [15,4]
C0178913
UMLS CUI [15,5]
C1511524
UMLS CUI [16,1]
C1520224
UMLS CUI [17,1]
C0750591
UMLS CUI [17,2]
C4527371
UMLS CUI [17,3]
C1704686
UMLS CUI [17,4]
C2607886
UMLS CUI [17,5]
C0032952
UMLS CUI [17,6]
C0231290
UMLS CUI [17,7]
C5200924
UMLS CUI [17,8]
C0279025
UMLS CUI [17,9]
C1298908
UMLS CUI [17,10]
C1301624
UMLS CUI [18,1]
C0030705
UMLS CUI [18,2]
C3539897
UMLS CUI [18,3]
C0457454
UMLS CUI [18,4]
C0279492
UMLS CUI [18,5]
C0439231
UMLS CUI [18,6]
C0332152
UMLS CUI [18,7]
C3173309
UMLS CUI [18,8]
C0304229
UMLS CUI [19,1]
C0030705
UMLS CUI [19,2]
C3539897
UMLS CUI [19,3]
C0457454
UMLS CUI [19,4]
C0205394
UMLS CUI [19,5]
C0087111
UMLS CUI [19,6]
C0033308
UMLS CUI [19,7]
C0025147
UMLS CUI [19,8]
C0033306
UMLS CUI [19,9]
C2936788
UMLS CUI [19,10]
C1442457
UMLS CUI [19,11]
C0332152
UMLS CUI [19,12]
C3173309
UMLS CUI [19,13]
C0304229
UMLS CUI [20,1]
C0680251
UMLS CUI [21,1]
C1524063
UMLS CUI [21,2]
C1442989
UMLS CUI [21,3]
C0087111
UMLS CUI [21,4]
C1328504
UMLS CUI [21,5]
C0205458
UMLS CUI [21,6]
C0439231
UMLS CUI [21,7]
C0332152
UMLS CUI [21,8]
C1514821
UMLS CUI [22,1]
C1524063
UMLS CUI [22,2]
C0246415
UMLS CUI [22,3]
C0392920
UMLS CUI [22,4]
C1328504
UMLS CUI [22,5]
C0205458
UMLS CUI [22,6]
C0439231
UMLS CUI [22,7]
C0332152
UMLS CUI [22,8]
C1514821
UMLS CUI [23,1]
C1298908
UMLS CUI [23,2]
C0680251
UMLS CUI [23,3]
C1524063
UMLS CUI [23,4]
C0246415
UMLS CUI [23,5]
C0087111
UMLS CUI [23,6]
C4302896
UMLS CUI [24,1]
C1524063
UMLS CUI [24,2]
C3541342
UMLS CUI [24,3]
C1328504
UMLS CUI [25,1]
C1524063
UMLS CUI [25,2]
C3236305
UMLS CUI [25,3]
C0205458
UMLS CUI [25,4]
C0439231
UMLS CUI [25,5]
C0332152
UMLS CUI [25,6]
C1514821
UMLS CUI [26,1]
C1298908
UMLS CUI [26,2]
C0680251
UMLS CUI [26,3]
C0439092
UMLS CUI [26,4]
C0205449
UMLS CUI [26,5]
C0178602
UMLS CUI [26,6]
C0750480
UMLS CUI [26,7]
C3236305
UMLS CUI [26,8]
C0332152
UMLS CUI [26,9]
C1514821
UMLS CUI [27,1]
C1705542
UMLS CUI [27,2]
C0439617
UMLS CUI [28,1]
C1704686
UMLS CUI [28,2]
C0443225
UMLS CUI [28,3]
C0178602
UMLS CUI [28,4]
C0392920
UMLS CUI [28,5]
C0026259
UMLS CUI [28,6]
C1328504
UMLS CUI [28,7]
C0205156
UMLS CUI [28,8]
C0205458
UMLS CUI [28,9]
C0439231
UMLS CUI [29,1]
C1524063
UMLS CUI [29,2]
C2830183
UMLS CUI [29,3]
C0392920
UMLS CUI [29,4]
C0205458
UMLS CUI [29,5]
C0439231
UMLS CUI [29,6]
C0332152
UMLS CUI [29,7]
C1514821
UMLS CUI [30,1]
C1298908
UMLS CUI [30,2]
C0680251
UMLS CUI [30,3]
C1704686
UMLS CUI [30,4]
C0443225
UMLS CUI [30,5]
C0178602
UMLS CUI [30,6]
C0392920
UMLS CUI [30,7]
C2830183
UMLS CUI [30,8]
C1328504
UMLS CUI [30,9]
C0205156
UMLS CUI [30,10]
C0205458
UMLS CUI [30,11]
C0439231
UMLS CUI [31,1]
C1524063
UMLS CUI [31,2]
C0022625
UMLS CUI [31,3]
C0038317
UMLS CUI [31,4]
C0205458
UMLS CUI [31,5]
C0439231
UMLS CUI [31,6]
C0332152
UMLS CUI [31,7]
C1514821
UMLS CUI [31,8]
C1328504
UMLS CUI [32,1]
C1298908
UMLS CUI [32,2]
C0680251
UMLS CUI [32,3]
C1524063
UMLS CUI [32,4]
C0022625
UMLS CUI [32,5]
C1272706
UMLS CUI [32,6]
C0347984
UMLS CUI [32,7]
C0205458
UMLS CUI [32,8]
C0439231
UMLS CUI [32,9]
C0332152
UMLS CUI [32,10]
C1514821
UMLS CUI [33,1]
C1524063
UMLS CUI [33,2]
C3496793
UMLS CUI [33,3]
C1328504
UMLS CUI [33,4]
C0205458
UMLS CUI [33,5]
C0439231
UMLS CUI [33,6]
C0332152
UMLS CUI [33,7]
C1514821
UMLS CUI [34,1]
C1524063
UMLS CUI [34,2]
C0015320
UMLS CUI [34,3]
C2936643
UMLS CUI [34,4]
C3846158
UMLS CUI [34,5]
C0205458
UMLS CUI [34,6]
C0439231
UMLS CUI [34,7]
C0332152
UMLS CUI [34,8]
C1514821
Note: Standard of care CRPC therapy with a CYP-17 inhibitor ≤7 days prior to registration is not an exclusion criterion. If taken for 8 days or more it will be counted as an exclusion criterion.
Beschreibung

Elig.phs001141.v1.p1.2

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C2936643
UMLS CUI [1,4]
C1328504
UMLS CUI [1,5]
C0087111
UMLS CUI [1,6]
C3846158
UMLS CUI [1,7]
C1442452
UMLS CUI [1,8]
C0332152
UMLS CUI [1,9]
C1514821
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C3846158
UMLS CUI [2,5]
C0439093
UMLS CUI [2,6]
C1442452
3.22 Receiving any intermittent hormonal treatment GnRH analogues and has not yet achieved sub-castrate levels of testosterone (<50 ng/dl or <1.7 mmol/L). 3.23 History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. Note: brain imaging for asymptomatic patients is not required. 3.24 Current symptomatic cord compression requiring surgery or radiation therapy. Note: Once successfully treated and there has been no progression, patients are eligible for the study. 3.25 Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring anticancer therapy or at high risk of recurrence during the study. 3.26 Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, disseminated on-going coagulopathy, stroke or treatment of a major active infection ≤3 months of registration, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy. 3.27 Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device.
Beschreibung

Elig.phs001141.v1.p1.3

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205267
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C2267073
UMLS CUI [1,4]
C1298908
UMLS CUI [1,5]
C0039601
UMLS CUI [1,6]
C0441889
UMLS CUI [1,7]
C0007347
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0686377
UMLS CUI [2,3]
C0220654
UMLS CUI [2,4]
C1522326
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0686377
UMLS CUI [3,3]
C0220654
UMLS CUI [3,4]
C0332155
UMLS CUI [4,1]
C1298908
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0203860
UMLS CUI [4,4]
C0231221
UMLS CUI [5,1]
C0521116
UMLS CUI [5,2]
C0231220
UMLS CUI [5,3]
C0037926
UMLS CUI [5,4]
C0332121
UMLS CUI [5,5]
C1522449
UMLS CUI [5,6]
C0543467
UMLS CUI [6,1]
C1302261
UMLS CUI [6,2]
C0580352
UMLS CUI [6,3]
C1272703
UMLS CUI [6,4]
C1298908
UMLS CUI [6,5]
C0242656
UMLS CUI [7,1]
C0751623
UMLS CUI [7,2]
C1705847
UMLS CUI [7,3]
C1336527
UMLS CUI [7,4]
C1518408
UMLS CUI [7,5]
C0699893
UMLS CUI [7,6]
C1514873
UMLS CUI [7,7]
C0920425
UMLS CUI [7,8]
C0332167
UMLS CUI [7,9]
C0277556
UMLS CUI [7,10]
C0347984
UMLS CUI [7,11]
C0008976
UMLS CUI [8,1]
C0205318
UMLS CUI [8,2]
C0018801
UMLS CUI [8,3]
C0027051
UMLS CUI [8,4]
C1868885
UMLS CUI [8,5]
C0012739
UMLS CUI [8,6]
C0038454
UMLS CUI [8,7]
C0332121
UMLS CUI [8,8]
C0205177
UMLS CUI [8,9]
C0205082
UMLS CUI [8,10]
C3714514
UMLS CUI [8,11]
C1442461
UMLS CUI [8,12]
C0332152
UMLS CUI [8,13]
C1514821
UMLS CUI [8,14]
C0750502
UMLS CUI [8,15]
C0348080
UMLS CUI [8,16]
C0332196
UMLS CUI [8,17]
C1522541
UMLS CUI [9,1]
C0521116
UMLS CUI [9,2]
C0679823
UMLS CUI [9,3]
C0205394
UMLS CUI [9,4]
C0008976
UMLS CUI [9,5]
C0304229
UMLS CUI [9,6]
C0042210
UMLS CUI [9,7]
C2346570
Note: Concomitant participation in observational studies is acceptable.
Beschreibung

Elig.phs001141.v1.p1.4

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C1518527
UMLS CUI [1,4]
C1298908
UMLS CUI [1,5]
C0680251
3.28 Patients with a global or severe deterioration of health status such that it requires discontinuation of standard of care treatments for CRPC stage without evidence of disease progression ≤ 12 weeks prior to registration.
Beschreibung

Elig.phs001141.v1.p1.5

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281858
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0868945
UMLS CUI [1,4]
C0018759
UMLS CUI [1,5]
C1514873
UMLS CUI [1,6]
C0457454
UMLS CUI [1,7]
C2936643
UMLS CUI [1,8]
C0087111
UMLS CUI [1,9]
C1328504
UMLS CUI [1,10]
C0332288
UMLS CUI [1,11]
C0332120
UMLS CUI [1,12]
C0242656
UMLS CUI [1,13]
C1442461
UMLS CUI [1,14]
C0332152
UMLS CUI [1,15]
C1514821
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Ähnliche Modelle

Eligibility Criteria

5 Formulare
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
    3. Subject ID, sample ID, sample source, source sample ID, and sample use variable obtained from Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
    4. Subject ID, age, race, composite endpoint for progression after 12 weeks of abiraterone acetate chemotherapy, and sex of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
    5. Sample ID, body site where sample was obtained, analyte type, primary or metastatic tumor, primary tumor location, tumor stage, tumor treatment, treatment post visit, histological type, sequence center, and body site category where sample was collected [bone or tissue] of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Elig.phs001141.v1.p1.1
Item
Inclusion Criteria 3.11 Males age ≥ 18 years. 3.12 Histological diagnosis of adenocarcinoma of the prostate or documented history in medical records of having received treatment for prostate cancer diagnosis. 3.13 Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan amenable to biopsy. 3.14 The following laboratory values obtained ≤14 days prior to registration a. Hematology: HgB >9.0 gm, ANC ≥ 1500 cells /L, and platelets ≥100,000μ/L b. Creatinine ≤ 1.5 x upper limit of normal (ULN). c. SGOT (AST) and SGPT (ALT) ≤ 1.5 x ULN. d. Castrate serum testosterone level (< 50 ng/dL-or-< 1.7 nmol/L). 3.15 Progression while on or after androgen deprivation therapy defined as: a. Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed or the appearance of one or more new lesions as assessed by imaging during hormone ablation treatment. Measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions ≥ 20 mm in diameter or visceral/soft-tissue lesions ≥ 10 mm in diameter (see Section 11.0). OR b. Bone Scan Progression: appearance of 2 or more new lesions on bone scan during hormone ablation treatment. OR c. Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 2.0 ng/mL is required for study enrollment. NOTE: Androgen deprivation therapy may have included either medical or surgical castration. 3.16 ≥14 days has passed since completing radiotherapy (exception for radiotherapy: ≥ 7 days since completing a single fraction of ≤ 800 cGy to 14 MC1351 Template revised: 1/30/2012 a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration. 3.17 Patients who may have received systemic chemotherapy or any novel therapeutic CYP-17 inhibitor and/or novel AR inhibitor agents previously for prostate cancer should have received the last dose of the previously administered systemic therapy ≥12 months from the date of registration. 3.18 Provide informed written consent. 3.19a Has recovered from any other therapy-related toxicity to ≤ grade 2, (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy). 3.19b Willing to provide tissue and blood samples for correlative research purposes (see Section 6.2, 14.1, and 17.1 of the protocol) 3.19c ECOG Performance Status (PS) 0, 1 or 2 (Appendix I). 3.19d Patient is considered a candidate for initiating CYP-17 inhibitors Abiraterone acetate and prednisone after failure of hormonal therapy and has no contra-indication to starting this combination as standard of care. 3.19e Patients have stopped any antiandrogen therapy (including bicalutamide) ≥4 weeks prior to first dose of study drug. In addition any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5-alpha reductase inhibitors (eg, finasteride or dutasteride), must be discontinued ≥2 weeks before the first dose of study drug. 3.2 Exclusion Criteria 3.21 Use of any of the standard therapies for CRPC stage ≤12 months prior to registration. a. Initiation of full dose chemotherapy with Docetaxel for CRPC stage ≤12 months prior to registration is an exclusion criterion. Note: Docetaxel for hormone sensitive prostate cancer is not an exclusion criterion. b. Use of Radium-223 for CRPC stage is an exclusion criteria. c. Use of Provenge vaccine for CRPC ≤12 months prior to registration is an exclusion criterion. Note: Less than 3 doses of Provenge vaccine ≤12 months prior to registration for CRPC is not an exclusion criterion. 15 MC1351 Template revised: 1/30/2012. d. Initiation of full dose chemotherapy with Mitoxantrone for CRPC stage with-in the previous 12 months is an exclusion criterion. e. Use of Cabazitaxel chemotherapy ≤12 months prior to registration is an exclusion criterion Note: Initiation of full dose chemotherapy with cabazitaxel for CRPC stage with-in the previous 12 months is an exclusion criterion. f. Use of Ketoconazole with steroids ≤12 months prior to registration for CRPC stage Note: Ketoconazole therapy taken for a time period of ≤12 weeks in the 12 month period prior to registration is not an exclusion criterion. g. Use of Enzalutamide for CRPC stage ≤12 months prior to registration is an exclusion criteria Use of any experimental or standard of care CYP-17 inhibitors ≤12 months prior to registration is an exclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C0001779 (UMLS CUI [2,1])
C0679557 (UMLS CUI [3,1])
C0007112 (UMLS CUI [3,2])
C0025102 (UMLS CUI [3,3])
C0087111 (UMLS CUI [3,4])
C0600139 (UMLS CUI [3,5])
C0027627 (UMLS CUI [4,1])
C0817096 (UMLS CUI [4,2])
C0000726 (UMLS CUI [4,3])
C0030797 (UMLS CUI [4,4])
C0040405 (UMLS CUI [4,5])
C0203668 (UMLS CUI [4,6])
C0005558 (UMLS CUI [4,7])
C1254595 (UMLS CUI [5,1])
C0332152 (UMLS CUI [5,2])
C1514821 (UMLS CUI [5,3])
C0019046 (UMLS CUI [5,4])
C0948762 (UMLS CUI [5,5])
C0032181 (UMLS CUI [5,6])
C0201976 (UMLS CUI [5,7])
C0201899 (UMLS CUI [5,8])
C0201836 (UMLS CUI [5,9])
C1319065 (UMLS CUI [5,10])
C0428413 (UMLS CUI [5,11])
C1335499 (UMLS CUI [6,1])
C0279492 (UMLS CUI [6,2])
C1704788 (UMLS CUI [6,3])
C1335499 (UMLS CUI [7,1])
C1704788 (UMLS CUI [7,2])
C0205217 (UMLS CUI [7,3])
C0221198 (UMLS CUI [7,4])
C1301886 (UMLS CUI [7,5])
C1522425 (UMLS CUI [7,6])
C0700364 (UMLS CUI [7,7])
C0205314 (UMLS CUI [7,8])
C0221198 (UMLS CUI [7,9])
C1516048 (UMLS CUI [7,10])
C0011923 (UMLS CUI [7,11])
C0347984 (UMLS CUI [7,12])
C0279492 (UMLS CUI [7,13])
C1335499 (UMLS CUI [8,1])
C1704788 (UMLS CUI [8,2])
C0203668 (UMLS CUI [8,3])
C0700364 (UMLS CUI [8,4])
C0205314 (UMLS CUI [8,5])
C0221198 (UMLS CUI [8,6])
C0347984 (UMLS CUI [8,7])
C0279492 (UMLS CUI [8,8])
C1335499 (UMLS CUI [9,1])
C1704788 (UMLS CUI [9,2])
C0205217 (UMLS CUI [9,3])
C0201544 (UMLS CUI [9,4])
C1524031 (UMLS CUI [9,5])
C0442719 (UMLS CUI [9,6])
C1514873 (UMLS CUI [9,7])
C1516879 (UMLS CUI [9,8])
C0279492 (UMLS CUI [10,1])
C1513054 (UMLS CUI [10,2])
C0007347 (UMLS CUI [10,3])
C0543467 (UMLS CUI [10,4])
C0449238 (UMLS CUI [11,1])
C1711239 (UMLS CUI [11,2])
C0205197 (UMLS CUI [11,3])
C1522449 (UMLS CUI [11,4])
C2348792 (UMLS CUI [11,5])
C1514821 (UMLS CUI [11,6])
C0205156 (UMLS CUI [12,1])
C1883256 (UMLS CUI [12,2])
C0087111 (UMLS CUI [12,3])
C3846158 (UMLS CUI [12,4])
C0600139 (UMLS CUI [12,5])
C1762893 (UMLS CUI [12,6])
C0449238 (UMLS CUI [12,7])
C0332152 (UMLS CUI [12,8])
C0011008 (UMLS CUI [12,9])
C1514821 (UMLS CUI [12,10])
C0021430 (UMLS CUI [13,1])
C1115804 (UMLS CUI [14,1])
C0600688 (UMLS CUI [14,2])
C0678226 (UMLS CUI [14,3])
C1514463 (UMLS CUI [14,4])
C1705847 (UMLS CUI [14,5])
C0002871 (UMLS CUI [14,6])
C0002170 (UMLS CUI [14,7])
C0037088 (UMLS CUI [14,8])
C0279492 (UMLS CUI [14,9])
C0600109 (UMLS CUI [15,1])
C1999230 (UMLS CUI [15,2])
C0040300 (UMLS CUI [15,3])
C0178913 (UMLS CUI [15,4])
C1511524 (UMLS CUI [15,5])
C1520224 (UMLS CUI [16,1])
C0750591 (UMLS CUI [17,1])
C4527371 (UMLS CUI [17,2])
C1704686 (UMLS CUI [17,3])
C2607886 (UMLS CUI [17,4])
C0032952 (UMLS CUI [17,5])
C0231290 (UMLS CUI [17,6])
C5200924 (UMLS CUI [17,7])
C0279025 (UMLS CUI [17,8])
C1298908 (UMLS CUI [17,9])
C1301624 (UMLS CUI [17,10])
C0030705 (UMLS CUI [18,1])
C3539897 (UMLS CUI [18,2])
C0457454 (UMLS CUI [18,3])
C0279492 (UMLS CUI [18,4])
C0439231 (UMLS CUI [18,5])
C0332152 (UMLS CUI [18,6])
C3173309 (UMLS CUI [18,7])
C0304229 (UMLS CUI [18,8])
C0030705 (UMLS CUI [19,1])
C3539897 (UMLS CUI [19,2])
C0457454 (UMLS CUI [19,3])
C0205394 (UMLS CUI [19,4])
C0087111 (UMLS CUI [19,5])
C0033308 (UMLS CUI [19,6])
C0025147 (UMLS CUI [19,7])
C0033306 (UMLS CUI [19,8])
C2936788 (UMLS CUI [19,9])
C1442457 (UMLS CUI [19,10])
C0332152 (UMLS CUI [19,11])
C3173309 (UMLS CUI [19,12])
C0304229 (UMLS CUI [19,13])
C0680251 (UMLS CUI [20,1])
C1524063 (UMLS CUI [21,1])
C1442989 (UMLS CUI [21,2])
C0087111 (UMLS CUI [21,3])
C1328504 (UMLS CUI [21,4])
C0205458 (UMLS CUI [21,5])
C0439231 (UMLS CUI [21,6])
C0332152 (UMLS CUI [21,7])
C1514821 (UMLS CUI [21,8])
C1524063 (UMLS CUI [22,1])
C0246415 (UMLS CUI [22,2])
C0392920 (UMLS CUI [22,3])
C1328504 (UMLS CUI [22,4])
C0205458 (UMLS CUI [22,5])
C0439231 (UMLS CUI [22,6])
C0332152 (UMLS CUI [22,7])
C1514821 (UMLS CUI [22,8])
C1298908 (UMLS CUI [23,1])
C0680251 (UMLS CUI [23,2])
C1524063 (UMLS CUI [23,3])
C0246415 (UMLS CUI [23,4])
C0087111 (UMLS CUI [23,5])
C4302896 (UMLS CUI [23,6])
C1524063 (UMLS CUI [24,1])
C3541342 (UMLS CUI [24,2])
C1328504 (UMLS CUI [24,3])
C1524063 (UMLS CUI [25,1])
C3236305 (UMLS CUI [25,2])
C0205458 (UMLS CUI [25,3])
C0439231 (UMLS CUI [25,4])
C0332152 (UMLS CUI [25,5])
C1514821 (UMLS CUI [25,6])
C1298908 (UMLS CUI [26,1])
C0680251 (UMLS CUI [26,2])
C0439092 (UMLS CUI [26,3])
C0205449 (UMLS CUI [26,4])
C0178602 (UMLS CUI [26,5])
C0750480 (UMLS CUI [26,6])
C3236305 (UMLS CUI [26,7])
C0332152 (UMLS CUI [26,8])
C1514821 (UMLS CUI [26,9])
C1705542 (UMLS CUI [27,1])
C0439617 (UMLS CUI [27,2])
C1704686 (UMLS CUI [28,1])
C0443225 (UMLS CUI [28,2])
C0178602 (UMLS CUI [28,3])
C0392920 (UMLS CUI [28,4])
C0026259 (UMLS CUI [28,5])
C1328504 (UMLS CUI [28,6])
C0205156 (UMLS CUI [28,7])
C0205458 (UMLS CUI [28,8])
C0439231 (UMLS CUI [28,9])
C1524063 (UMLS CUI [29,1])
C2830183 (UMLS CUI [29,2])
C0392920 (UMLS CUI [29,3])
C0205458 (UMLS CUI [29,4])
C0439231 (UMLS CUI [29,5])
C0332152 (UMLS CUI [29,6])
C1514821 (UMLS CUI [29,7])
C1298908 (UMLS CUI [30,1])
C0680251 (UMLS CUI [30,2])
C1704686 (UMLS CUI [30,3])
C0443225 (UMLS CUI [30,4])
C0178602 (UMLS CUI [30,5])
C0392920 (UMLS CUI [30,6])
C2830183 (UMLS CUI [30,7])
C1328504 (UMLS CUI [30,8])
C0205156 (UMLS CUI [30,9])
C0205458 (UMLS CUI [30,10])
C0439231 (UMLS CUI [30,11])
C1524063 (UMLS CUI [31,1])
C0022625 (UMLS CUI [31,2])
C0038317 (UMLS CUI [31,3])
C0205458 (UMLS CUI [31,4])
C0439231 (UMLS CUI [31,5])
C0332152 (UMLS CUI [31,6])
C1514821 (UMLS CUI [31,7])
C1328504 (UMLS CUI [31,8])
C1298908 (UMLS CUI [32,1])
C0680251 (UMLS CUI [32,2])
C1524063 (UMLS CUI [32,3])
C0022625 (UMLS CUI [32,4])
C1272706 (UMLS CUI [32,5])
C0347984 (UMLS CUI [32,6])
C0205458 (UMLS CUI [32,7])
C0439231 (UMLS CUI [32,8])
C0332152 (UMLS CUI [32,9])
C1514821 (UMLS CUI [32,10])
C1524063 (UMLS CUI [33,1])
C3496793 (UMLS CUI [33,2])
C1328504 (UMLS CUI [33,3])
C0205458 (UMLS CUI [33,4])
C0439231 (UMLS CUI [33,5])
C0332152 (UMLS CUI [33,6])
C1514821 (UMLS CUI [33,7])
C1524063 (UMLS CUI [34,1])
C0015320 (UMLS CUI [34,2])
C2936643 (UMLS CUI [34,3])
C3846158 (UMLS CUI [34,4])
C0205458 (UMLS CUI [34,5])
C0439231 (UMLS CUI [34,6])
C0332152 (UMLS CUI [34,7])
C1514821 (UMLS CUI [34,8])
Elig.phs001141.v1.p1.2
Item
Note: Standard of care CRPC therapy with a CYP-17 inhibitor ≤7 days prior to registration is not an exclusion criterion. If taken for 8 days or more it will be counted as an exclusion criterion.
boolean
C1298908 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C2936643 (UMLS CUI [1,3])
C1328504 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,5])
C3846158 (UMLS CUI [1,6])
C1442452 (UMLS CUI [1,7])
C0332152 (UMLS CUI [1,8])
C1514821 (UMLS CUI [1,9])
C0680251 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C3846158 (UMLS CUI [2,4])
C0439093 (UMLS CUI [2,5])
C1442452 (UMLS CUI [2,6])
Elig.phs001141.v1.p1.3
Item
3.22 Receiving any intermittent hormonal treatment GnRH analogues and has not yet achieved sub-castrate levels of testosterone (<50 ng/dl or <1.7 mmol/L). 3.23 History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. Note: brain imaging for asymptomatic patients is not required. 3.24 Current symptomatic cord compression requiring surgery or radiation therapy. Note: Once successfully treated and there has been no progression, patients are eligible for the study. 3.25 Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring anticancer therapy or at high risk of recurrence during the study. 3.26 Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, disseminated on-going coagulopathy, stroke or treatment of a major active infection ≤3 months of registration, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy. 3.27 Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device.
boolean
C0205267 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C2267073 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C0039601 (UMLS CUI [1,5])
C0441889 (UMLS CUI [1,6])
C0007347 (UMLS CUI [1,7])
C0262926 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C0220654 (UMLS CUI [2,3])
C1522326 (UMLS CUI [2,4])
C0262926 (UMLS CUI [3,1])
C0686377 (UMLS CUI [3,2])
C0220654 (UMLS CUI [3,3])
C0332155 (UMLS CUI [3,4])
C1298908 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0203860 (UMLS CUI [4,3])
C0231221 (UMLS CUI [4,4])
C0521116 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C0037926 (UMLS CUI [5,3])
C0332121 (UMLS CUI [5,4])
C1522449 (UMLS CUI [5,5])
C0543467 (UMLS CUI [5,6])
C1302261 (UMLS CUI [6,1])
C0580352 (UMLS CUI [6,2])
C1272703 (UMLS CUI [6,3])
C1298908 (UMLS CUI [6,4])
C0242656 (UMLS CUI [6,5])
C0751623 (UMLS CUI [7,1])
C1705847 (UMLS CUI [7,2])
C1336527 (UMLS CUI [7,3])
C1518408 (UMLS CUI [7,4])
C0699893 (UMLS CUI [7,5])
C1514873 (UMLS CUI [7,6])
C0920425 (UMLS CUI [7,7])
C0332167 (UMLS CUI [7,8])
C0277556 (UMLS CUI [7,9])
C0347984 (UMLS CUI [7,10])
C0008976 (UMLS CUI [7,11])
C0205318 (UMLS CUI [8,1])
C0018801 (UMLS CUI [8,2])
C0027051 (UMLS CUI [8,3])
C1868885 (UMLS CUI [8,4])
C0012739 (UMLS CUI [8,5])
C0038454 (UMLS CUI [8,6])
C0332121 (UMLS CUI [8,7])
C0205177 (UMLS CUI [8,8])
C0205082 (UMLS CUI [8,9])
C3714514 (UMLS CUI [8,10])
C1442461 (UMLS CUI [8,11])
C0332152 (UMLS CUI [8,12])
C1514821 (UMLS CUI [8,13])
C0750502 (UMLS CUI [8,14])
C0348080 (UMLS CUI [8,15])
C0332196 (UMLS CUI [8,16])
C1522541 (UMLS CUI [8,17])
C0521116 (UMLS CUI [9,1])
C0679823 (UMLS CUI [9,2])
C0205394 (UMLS CUI [9,3])
C0008976 (UMLS CUI [9,4])
C0304229 (UMLS CUI [9,5])
C0042210 (UMLS CUI [9,6])
C2346570 (UMLS CUI [9,7])
Elig.phs001141.v1.p1.4
Item
Note: Concomitant participation in observational studies is acceptable.
boolean
C0521116 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C1518527 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C0680251 (UMLS CUI [1,5])
Elig.phs001141.v1.p1.5
Item
3.28 Patients with a global or severe deterioration of health status such that it requires discontinuation of standard of care treatments for CRPC stage without evidence of disease progression ≤ 12 weeks prior to registration.
boolean
C0281858 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0868945 (UMLS CUI [1,3])
C0018759 (UMLS CUI [1,4])
C1514873 (UMLS CUI [1,5])
C0457454 (UMLS CUI [1,6])
C2936643 (UMLS CUI [1,7])
C0087111 (UMLS CUI [1,8])
C1328504 (UMLS CUI [1,9])
C0332288 (UMLS CUI [1,10])
C0332120 (UMLS CUI [1,11])
C0242656 (UMLS CUI [1,12])
C1442461 (UMLS CUI [1,13])
C0332152 (UMLS CUI [1,14])
C1514821 (UMLS CUI [1,15])
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