ID

31646

Description

A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00992745

Lien

https://clinicaltrials.gov/show/NCT00992745

Mots-clés

Versions (2)
  1. 16/09/2018 16/09/2018 -
  2. 16/09/2018 16/09/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 septembre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00992745

Anglais

Eligibility Prostate Cancer NCT00992745

1 Formulaires  
Criteria
Description

Criteria

1. male aged 18 years or older
Description

Gender | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. signed written informed consent and willingness to comply with protocol requirements
Description

Informed Consent | Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
3. histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a metastatic lesion.
Description

Prostate carcinoma | Prostate Medical History | Biopsy of prostate | Metastatic Lesion Biopsy

Type de données

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C0033572
UMLS CUI [2,2]
C0262926
UMLS CUI [3]
C0194804
UMLS CUI [4,1]
C1513183
UMLS CUI [4,2]
C0005558
4. evidence of metastatic disease as documented by an abnormal bone scan and ct scan or mri plus:
Description

Neoplasm Metastasis Bone scan abnormal | Neoplasm Metastasis CT scan abnormal | Neoplasm Metastasis MRI scan abnormal

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0740353
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0436539
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0436540
castration/anti androgen therapy naïve/sensitive:
Description

Castration naive | Castration Sensitive | Antiandrogen therapy naive | Antiandrogen therapy Sensitive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007344
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0007344
UMLS CUI [2,2]
C0332324
UMLS CUI [3,1]
C0279492
UMLS CUI [3,2]
C0919936
UMLS CUI [4,1]
C0279492
UMLS CUI [4,2]
C0332324
1. gleason score ≥ 7 and psa ≥ 2.0 ng/ml with history of prostatectomy or primary radiation therapy of the prostate gland and prior undetectable psa or; psa > 10.0 ng/ml if intact prostate, or
Description

Gleason score | Prostate specific antigen measurement | Relationship Prostate Intact | Prostatectomy | Therapeutic radiology procedure Primary Prostatic gland | Prostate-Specific Antigen Previous Undetectable

Type de données

boolean

Alias
UMLS CUI [1]
C3203027
UMLS CUI [2]
C0201544
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0033572
UMLS CUI [3,3]
C0205266
UMLS CUI [4]
C0033573
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C0205225
UMLS CUI [5,3]
C0458690
UMLS CUI [6,1]
C0138741
UMLS CUI [6,2]
C0205156
UMLS CUI [6,3]
C3827727
2. gleason score ≤ 6 and psa is ≥ 20 ng/ml, or
Description

Gleason score | Prostate specific antigen measurement

Type de données

boolean

Alias
UMLS CUI [1]
C3203027
UMLS CUI [2]
C0201544
3. gleason score ≥ 8 and any doubling of psa, or psa > 0.5 ng/ml, or
Description

Gleason score | Prostate-Specific Antigen Doubling Time | Prostate specific antigen measurement

Type de données

boolean

Alias
UMLS CUI [1]
C3203027
UMLS CUI [2,1]
C0138741
UMLS CUI [2,2]
C2986483
UMLS CUI [3]
C0201544
4. clinical stage 3 and gleason score ≥ 8
Description

TNM clinical staging | Gleason score

Type de données

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3203027
if on anti androgen therapy, must have initiated therapy at least 4 weeks prior to treatment.
Description

Antiandrogen therapy Initiation Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C1704686
UMLS CUI [1,3]
C0205156
castration/anti androgen therapy resistant:
Description

Castration Resistant | Antiandrogen therapy Resistant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007344
UMLS CUI [1,2]
C0332325
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C0332325
1. 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 anti androgens who have demonstrated a > 3 month duration of beneficial response to anti androgens; progression is demonstrated by any of the following:
Description

Disease Progression | Male Castration | Orchiectomy | Medical Castration | LHRH Analogs | Androgen Antagonists Withdrawal | Flutamide | nilutamide | bicalutamide | Androgen Antagonists Response

Type de données

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0007347
UMLS CUI [3]
C0029189
UMLS CUI [4]
C1513054
UMLS CUI [5]
C1518041
UMLS CUI [6,1]
C0002842
UMLS CUI [6,2]
C2349954
UMLS CUI [7]
C0016384
UMLS CUI [8]
C0068771
UMLS CUI [9]
C0285590
UMLS CUI [10,1]
C0002842
UMLS CUI [10,2]
C1704632
i. psa progression: 2 serial rising psa determinations at least 14 days apart over the psa nadir, with the last measurement ≥ 2 ng/ml
Description

Prostate-Specific Antigen Progression | Raised prostate specific antigen Quantity | Prostate specific antigen measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C0449258
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0201544
ii. progression of measurable disease, or progression of non measurable disease as defined by:
Description

Measurable Disease Progression | Disease Progression

Type de données

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0242656
UMLS CUI [2]
C0242656
i. soft tissue disease: the appearance of one or more new lesions, and/or unequivocal worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response, or ii. bone disease: appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre castration studies if there was no response.
Description

Disorder of soft tissue | Lesion New Quantity | Disease Worsening | Bone Diseases | Bone scan abnormal Quantity

Type de données

boolean

Alias
UMLS CUI [1]
C0263978
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205314
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332271
UMLS CUI [4]
C0005940
UMLS CUI [5,1]
C0740353
UMLS CUI [5,2]
C1265611
iii. increased uptake of pre existing lesions on bone scan does not constitute progression.
Description

Lesion Pre-existing Increased Bone scan | Independent of Progression

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0205217
UMLS CUI [1,4]
C0203668
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0242656
iv. testosterone ≤ 50 ng/dl achieved via medical or surgical castration.
Description

Testosterone measurement | Medical Castration | Male Castration

Type de données

boolean

Alias
UMLS CUI [1]
C0523912
UMLS CUI [2]
C1513054
UMLS CUI [3]
C0007347
5. male subjects who are fertile agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method throughout the study period. a second form of barrier birth control must be utilized if a subject's partner is using oral contraception until at least seven days after the last injection.
Description

Gender | Fertility Contraceptive methods | Sexual Abstinence | Contraception, Barrier | Relationship Partner Oral contraception

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0015895
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0036899
UMLS CUI [4]
C0004764
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C0682323
UMLS CUI [5,3]
C0029151
6. karnofsky performance is ≥ 50
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
7. adequate hematologic, renal and liver function:
Description

Hematologic function | Renal function | Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
wbc ≥ 2.0×103/mm3 (anc > 1.0 x 103 mm3)
Description

White Blood Cell Count procedure | Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
platelet count ≥ 75×103/mm3
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 9.0 g/dl
Description

Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
creatinine ≤ 2.5 mg/dl
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin ≤ 2x uln
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
ast, alt ≤ 5x uln
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. karnofsky performance status of < 50
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
2. subject has received a permanent prostate brachytherapy implant within the last 3 months for 103pd implants or 12 months for 125i implants
Description

Prostate implant brachytherapy Permanent | Palladium-103 Implants | Iodine-125 Implants

Type de données

boolean

Alias
UMLS CUI [1,1]
C0860343
UMLS CUI [1,2]
C0205355
UMLS CUI [2,1]
C0303566
UMLS CUI [2,2]
C0021102
UMLS CUI [3,1]
C0796396
UMLS CUI [3,2]
C0021102
3. subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
Description

Diagnostic radioisotope

Type de données

boolean

Alias
UMLS CUI [1]
C0360048
4. subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study
Description

Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
UMLS CUI [3]
C2348568
5. any treatment with radiopharmaceuticals, e.g. strontium 89 and samarium 153 within 6 months prior to enrollment
Description

Radiopharmaceuticals | Strontium-89 | Samarium 153

Type de données

boolean

Alias
UMLS CUI [1]
C0182638
UMLS CUI [2]
C0281385
UMLS CUI [3]
C0677942
6. ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. patients who demonstrate an antiandrogen 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
Description

Ketoconazole | Androgen Antagonists | Flutamide | nilutamide | bicalutamide | Androgen Antagonists Withdrawal Response | Prostatic specific antigen decreased | Nonsteroidal Anti-Androgens Discontinued

Type de données

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2]
C0002842
UMLS CUI [3]
C0016384
UMLS CUI [4]
C0068771
UMLS CUI [5]
C0285590
UMLS CUI [6,1]
C0002842
UMLS CUI [6,2]
C2349954
UMLS CUI [6,3]
C1704632
UMLS CUI [7]
C0178414
UMLS CUI [8,1]
C1320169
UMLS CUI [8,2]
C1444662
7. initiation of bisphosphonate therapy within 28 days prior to enrollment. patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study
Description

Diphosphonates Dosage unchanged

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
8. subject has any medical condition or other circumstances which, in the opinion of the investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow up examinations
Description

Medical condition compromises Research data | Medical condition compromises Study Protocol | Medical condition compromises Completion of clinical trial | Medical condition compromises Follow-up | Circumstances compromise Research data | Circumstances compromise Study Protocol | Circumstances compromise Completion of clinical trial | Circumstances compromise Follow-up

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0681873
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348563
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C2732579
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C3274571
UMLS CUI [5,1]
C1821459
UMLS CUI [5,2]
C2945640
UMLS CUI [5,3]
C0681873
UMLS CUI [6,1]
C1821459
UMLS CUI [6,2]
C2945640
UMLS CUI [6,3]
C2348563
UMLS CUI [7,1]
C1821459
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C2732579
UMLS CUI [8,1]
C1821459
UMLS CUI [8,2]
C2945640
UMLS CUI [8,3]
C3274571
9. subject is determined by the investigator to be clinically unsuitable for the study
Description

Study Subject Participation Status Inappropriate

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
10. if the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response
Description

Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Requirement Cancer Other Diagnosed | Requirement Cancer Other Location | Requirement Cancer Other Controlled | Requirement Cancer Other In complete remission

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C1707251
UMLS CUI [4,3]
C0011900
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C1707251
UMLS CUI [5,3]
C1515974
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C1707251
UMLS CUI [6,3]
C2911690
UMLS CUI [7,1]
C1514873
UMLS CUI [7,2]
C1707251
UMLS CUI [7,3]
C0677874
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Similar models

Eligibility Prostate Cancer NCT00992745

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Gender | Age
Item
1. male aged 18 years or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent | Protocol Compliance
Item
2. signed written informed consent and willingness to comply with protocol requirements
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Prostate carcinoma | Prostate Medical History | Biopsy of prostate | Metastatic Lesion Biopsy
Item
3. histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a metastatic lesion.
boolean
C0600139 (UMLS CUI [1])
C0033572 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0194804 (UMLS CUI [3])
C1513183 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
Neoplasm Metastasis Bone scan abnormal | Neoplasm Metastasis CT scan abnormal | Neoplasm Metastasis MRI scan abnormal
Item
4. evidence of metastatic disease as documented by an abnormal bone scan and ct scan or mri plus:
boolean
C0027627 (UMLS CUI [1,1])
C0740353 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0436539 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0436540 (UMLS CUI [3,2])
Castration naive | Castration Sensitive | Antiandrogen therapy naive | Antiandrogen therapy Sensitive
Item
castration/anti androgen therapy naïve/sensitive:
boolean
C0007344 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0007344 (UMLS CUI [2,1])
C0332324 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3,1])
C0919936 (UMLS CUI [3,2])
C0279492 (UMLS CUI [4,1])
C0332324 (UMLS CUI [4,2])
Gleason score | Prostate specific antigen measurement | Relationship Prostate Intact | Prostatectomy | Therapeutic radiology procedure Primary Prostatic gland | Prostate-Specific Antigen Previous Undetectable
Item
1. gleason score ≥ 7 and psa ≥ 2.0 ng/ml with history of prostatectomy or primary radiation therapy of the prostate gland and prior undetectable psa or; psa > 10.0 ng/ml if intact prostate, or
boolean
C3203027 (UMLS CUI [1])
C0201544 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0033572 (UMLS CUI [3,2])
C0205266 (UMLS CUI [3,3])
C0033573 (UMLS CUI [4])
C1522449 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C0458690 (UMLS CUI [5,3])
C0138741 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
C3827727 (UMLS CUI [6,3])
Gleason score | Prostate specific antigen measurement
Item
2. gleason score ≤ 6 and psa is ≥ 20 ng/ml, or
boolean
C3203027 (UMLS CUI [1])
C0201544 (UMLS CUI [2])
Gleason score | Prostate-Specific Antigen Doubling Time | Prostate specific antigen measurement
Item
3. gleason score ≥ 8 and any doubling of psa, or psa > 0.5 ng/ml, or
boolean
C3203027 (UMLS CUI [1])
C0138741 (UMLS CUI [2,1])
C2986483 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])
TNM clinical staging | Gleason score
Item
4. clinical stage 3 and gleason score ≥ 8
boolean
C3258246 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
Antiandrogen therapy Initiation Previous
Item
if on anti androgen therapy, must have initiated therapy at least 4 weeks prior to treatment.
boolean
C0279492 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Castration Resistant | Antiandrogen therapy Resistant
Item
castration/anti androgen therapy resistant:
boolean
C0007344 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0279492 (UMLS CUI [2,1])
C0332325 (UMLS CUI [2,2])
Disease Progression | Male Castration | Orchiectomy | Medical Castration | LHRH Analogs | Androgen Antagonists Withdrawal | Flutamide | nilutamide | bicalutamide | Androgen Antagonists Response
Item
1. 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 anti androgens who have demonstrated a > 3 month duration of beneficial response to anti androgens; progression is demonstrated by any of the following:
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])
C0002842 (UMLS CUI [10,1])
C1704632 (UMLS CUI [10,2])
Prostate-Specific Antigen Progression | Raised prostate specific antigen Quantity | Prostate specific antigen measurement
Item
i. psa progression: 2 serial rising psa determinations at least 14 days apart over the psa nadir, with the last measurement ≥ 2 ng/ml
boolean
C0138741 (UMLS CUI [1,1])
C0449258 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])
Measurable Disease Progression | Disease Progression
Item
ii. progression of measurable disease, or progression of non measurable disease as defined by:
boolean
C1513041 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
Disorder of soft tissue | Lesion New Quantity | Disease Worsening | Bone Diseases | Bone scan abnormal Quantity
Item
i. soft tissue disease: the appearance of one or more new lesions, and/or unequivocal worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response, or ii. bone disease: appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre castration studies if there was no response.
boolean
C0263978 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0005940 (UMLS CUI [4])
C0740353 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Lesion Pre-existing Increased Bone scan | Independent of Progression
Item
iii. increased uptake of pre existing lesions on bone scan does not constitute progression.
boolean
C0221198 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
C0203668 (UMLS CUI [1,4])
C0332291 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Testosterone measurement | Medical Castration | Male Castration
Item
iv. testosterone ≤ 50 ng/dl achieved via medical or surgical castration.
boolean
C0523912 (UMLS CUI [1])
C1513054 (UMLS CUI [2])
C0007347 (UMLS CUI [3])
Gender | Fertility Contraceptive methods | Sexual Abstinence | Contraception, Barrier | Relationship Partner Oral contraception
Item
5. male subjects who are fertile agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method throughout the study period. a second form of barrier birth control must be utilized if a subject's partner is using oral contraception until at least seven days after the last injection.
boolean
C0079399 (UMLS CUI [1])
C0015895 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0036899 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0439849 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0029151 (UMLS CUI [5,3])
Karnofsky Performance Status
Item
6. karnofsky performance is ≥ 50
boolean
C0206065 (UMLS CUI [1])
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])
White Blood Cell Count procedure | Absolute neutrophil count
Item
wbc ≥ 2.0×103/mm3 (anc > 1.0 x 103 mm3)
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count ≥ 75×103/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine ≤ 2.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤ 2x uln
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast, alt ≤ 5x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Karnofsky Performance Status
Item
1. karnofsky performance status of < 50
boolean
C0206065 (UMLS CUI [1])
Prostate implant brachytherapy Permanent | Palladium-103 Implants | Iodine-125 Implants
Item
2. subject has received a permanent prostate brachytherapy implant within the last 3 months for 103pd implants or 12 months for 125i implants
boolean
C0860343 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C0303566 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C0796396 (UMLS CUI [3,1])
C0021102 (UMLS CUI [3,2])
Diagnostic radioisotope
Item
3. subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
boolean
C0360048 (UMLS CUI [1])
Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status
Item
4. subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
Radiopharmaceuticals | Strontium-89 | Samarium 153
Item
5. any treatment with radiopharmaceuticals, e.g. strontium 89 and samarium 153 within 6 months prior to enrollment
boolean
C0182638 (UMLS CUI [1])
C0281385 (UMLS CUI [2])
C0677942 (UMLS CUI [3])
Ketoconazole | Androgen Antagonists | Flutamide | nilutamide | bicalutamide | Androgen Antagonists Withdrawal Response | Prostatic specific antigen decreased | Nonsteroidal Anti-Androgens Discontinued
Item
6. ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. patients who demonstrate an antiandrogen 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])
C1704632 (UMLS CUI [6,3])
C0178414 (UMLS CUI [7])
C1320169 (UMLS CUI [8,1])
C1444662 (UMLS CUI [8,2])
Diphosphonates Dosage unchanged
Item
7. initiation of bisphosphonate therapy within 28 days prior to enrollment. patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study
boolean
C0012544 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Medical condition compromises Research data | Medical condition compromises Study Protocol | Medical condition compromises Completion of clinical trial | Medical condition compromises Follow-up | Circumstances compromise Research data | Circumstances compromise Study Protocol | Circumstances compromise Completion of clinical trial | Circumstances compromise Follow-up
Item
8. subject has any medical condition or other circumstances which, in the opinion of the investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow up examinations
boolean
C3843040 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
C1821459 (UMLS CUI [5,1])
C2945640 (UMLS CUI [5,2])
C0681873 (UMLS CUI [5,3])
C1821459 (UMLS CUI [6,1])
C2945640 (UMLS CUI [6,2])
C2348563 (UMLS CUI [6,3])
C1821459 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C1821459 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C3274571 (UMLS CUI [8,3])
Study Subject Participation Status Inappropriate
Item
9. subject is determined by the investigator to be clinically unsuitable for the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Requirement Cancer Other Diagnosed | Requirement Cancer Other Location | Requirement Cancer Other Controlled | Requirement Cancer Other In complete remission
Item
10. if the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C0011900 (UMLS CUI [4,3])
C1514873 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C1515974 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C1707251 (UMLS CUI [6,2])
C2911690 (UMLS CUI [6,3])
C1514873 (UMLS CUI [7,1])
C1707251 (UMLS CUI [7,2])
C0677874 (UMLS CUI [7,3])
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