ID

31580

Description

Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents; ODM derived from: https://clinicaltrials.gov/show/NCT00712829

Link

https://clinicaltrials.gov/show/NCT00712829

Keywords

Versions (1)
  1. 9/7/18 9/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00712829

English

Eligibility Prostate Cancer NCT00712829

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a prior histological diagnosis of prostate cancer.
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, ct scan or mri plus:
Description

Metastatic/Recurrent Disease Bone scan abnormal | Metastatic/Recurrent Disease CT scan abnormal | Metastatic/Recurrent Disease MRI scan abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C1334739
UMLS CUI [1,2]
C0740353
UMLS CUI [2,1]
C1334739
UMLS CUI [2,2]
C0436539
UMLS CUI [3,1]
C1334739
UMLS CUI [3,2]
C0436540
1. psa> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
Description

Prostate specific antigen measurement Post Prostatectomy | Prostate specific antigen measurement Post Stereotactic Ablative Radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0201544
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0033573
UMLS CUI [2,1]
C0201544
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C3896609
2. psa> 20 if intact prostate
Description

Prostate specific antigen measurement | Prostate Intact

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0033572
UMLS CUI [2,2]
C0205266
have platelet count of > 50,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
have neutrophil count of > 1,000/mm3
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
provide written informed consent and willing to comply with protocol requirements
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
greater than or equal to 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
can be on hormonal therapy if dose stable for > 90 days
Description

Hormone Therapy Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
karnofsky performance status of <60
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and pk blood sampling, respectively)
Description

Poor venous access

Data type

boolean

Alias
UMLS CUI [1]
C0577866
patient received a permanent prostate brachytherapy implant within the last 3 months (for pd-103 implants) or 12 months (for i-125 implants).
Description

Prostate implant brachytherapy Permanent | Palladium-103 Implant | I 125 Implant

Data type

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]
C3198030
patient received external beam therapy or chemotherapy within the last 30 days
Description

External beam radiotherapy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0419095
UMLS CUI [2]
C0392920
administered a radioisotope within 5 physical half lives prior to study enrollment
Description

Radioisotope administered

Data type

boolean

Alias
UMLS CUI [1,1]
C0034595
UMLS CUI [1,2]
C1521801
serum creatinine > 3.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin > 2.5 times the upper limit of normal
Description

Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0741494
liver transaminases greater than 5x the upper limit of normal
Description

Increased liver transaminases

Data type

boolean

Alias
UMLS CUI [1]
C4478596
received an investigational compound and/or medical device or is 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 | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
UMLS CUI [3]
C2348568
UMLS CUI [4]
C0008976
have 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 Interferes with Research data | Medical condition Interferes with Protocol Compliance | Environmental circumstances Interfere with Research data | Environmental circumstances Interfere with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681873
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C1821459
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0681873
UMLS CUI [4,1]
C1821459
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
is determined by the investigator that the patient is clinically unsuitable for the study
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
Description

Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Data type

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
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Similar models

Eligibility Prostate Cancer NCT00712829

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
have a prior histological diagnosis of prostate cancer.
boolean
C0600139 (UMLS CUI [1])
Metastatic/Recurrent Disease Bone scan abnormal | Metastatic/Recurrent Disease CT scan abnormal | Metastatic/Recurrent Disease MRI scan abnormal
Item
have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan, ct scan or mri plus:
boolean
C1334739 (UMLS CUI [1,1])
C0740353 (UMLS CUI [1,2])
C1334739 (UMLS CUI [2,1])
C0436539 (UMLS CUI [2,2])
C1334739 (UMLS CUI [3,1])
C0436540 (UMLS CUI [3,2])
Prostate specific antigen measurement Post Prostatectomy | Prostate specific antigen measurement Post Stereotactic Ablative Radiotherapy
Item
1. psa> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or
boolean
C0201544 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0033573 (UMLS CUI [1,3])
C0201544 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C3896609 (UMLS CUI [2,3])
Prostate specific antigen measurement | Prostate Intact
Item
2. psa> 20 if intact prostate
boolean
C0201544 (UMLS CUI [1])
C0033572 (UMLS CUI [2,1])
C0205266 (UMLS CUI [2,2])
Platelet Count measurement
Item
have platelet count of > 50,000/mm3
boolean
C0032181 (UMLS CUI [1])
Neutrophil count
Item
have neutrophil count of > 1,000/mm3
boolean
C0200633 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
provide written informed consent and willing to comply with protocol requirements
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Age
Item
greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
Hormone Therapy Dose Stable
Item
can be on hormonal therapy if dose stable for > 90 days
boolean
C0279025 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Karnofsky Performance Status
Item
karnofsky performance status of <60
boolean
C0206065 (UMLS CUI [1])
Poor venous access
Item
inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and pk blood sampling, respectively)
boolean
C0577866 (UMLS CUI [1])
Prostate implant brachytherapy Permanent | Palladium-103 Implant | I 125 Implant
Item
patient received a permanent prostate brachytherapy implant within the last 3 months (for pd-103 implants) or 12 months (for i-125 implants).
boolean
C0860343 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C0303566 (UMLS CUI [2,1])
C0021102 (UMLS CUI [2,2])
C3198030 (UMLS CUI [3])
External beam radiotherapy | Chemotherapy
Item
patient received external beam therapy or chemotherapy within the last 30 days
boolean
C0419095 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Radioisotope administered
Item
administered a radioisotope within 5 physical half lives prior to study enrollment
boolean
C0034595 (UMLS CUI [1,1])
C1521801 (UMLS CUI [1,2])
Creatinine measurement, serum
Item
serum creatinine > 3.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Elevated total bilirubin
Item
total bilirubin > 2.5 times the upper limit of normal
boolean
C0741494 (UMLS CUI [1])
Increased liver transaminases
Item
liver transaminases greater than 5x the upper limit of normal
boolean
C4478596 (UMLS CUI [1])
Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status | Clinical Trial
Item
received an investigational compound and/or medical device or is 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])
C0008976 (UMLS CUI [4])
Medical condition Interferes with Research data | Medical condition Interferes with Protocol Compliance | Environmental circumstances Interfere with Research data | Environmental circumstances Interfere with Protocol Compliance
Item
have 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])
C0521102 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C1821459 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0681873 (UMLS CUI [3,3])
C1821459 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Study Subject Participation Status Inappropriate
Item
is determined by the investigator that the patient is 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
Item
have had any other malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
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])
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