ID

35188

Description

A Study to Evaluate Once-Daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02361086

Link

https://clinicaltrials.gov/show/NCT02361086

Keywords

Versions (1)
  1. 2/22/19 2/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Castration-resistant Prostate Cancer NCT02361086

English

Eligibility Castration-resistant Prostate Cancer NCT02361086

1 forms  
Criteria
Description

Criteria

patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
patients must have a minimum serum psa level of >2 ng/ml that is rising based on the prostate cancer working group 2 criteria.
Description

Serum Prostate Specific Antigen Increased

Data type

boolean

Alias
UMLS CUI [1]
C1883014
patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]).
Description

Testosterone measurement Castration Level

Data type

boolean

Alias
UMLS CUI [1,1]
C0523912
UMLS CUI [1,2]
C0007344
UMLS CUI [1,3]
C0441889
patients must have undergone orchiectomy, or have been on lhrh agonists or antagonists, for at least 3 months prior to study entry. patients on lhrh agonists/antagonists must remain on these agents for the duration of the study.
Description

Orchiectomy | Luteinizing Hormone-releasing Hormone Agonist | LHRH antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0029189
UMLS CUI [2]
C1518041
UMLS CUI [3,1]
C0023610
UMLS CUI [3,2]
C0243076
patients must have an ecog performance score of 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
Description

Cytotoxic Chemotherapy Castration-Resistant Prostatic Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C3658266
patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
Description

Second line Antihormone Therapy | Ketoconazole | Aminoglutethimide | Estrogens High dose

Data type

boolean

Alias
UMLS CUI [1,1]
C1710038
UMLS CUI [1,2]
C2986607
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0002555
UMLS CUI [4,1]
C0014939
UMLS CUI [4,2]
C0444956
patients who have completed sipuleucel-t (provenge ®) treatment within 30 days of study entry.
Description

sipuleucel-T | Provenge

Data type

boolean

Alias
UMLS CUI [1]
C1706668
UMLS CUI [2]
C1135133
patients who have received tok-001 (galeterone®) or any other investigational product directed towards the androgen receptor or androgen biosynthesis.
Description

TOK-001 | Galeterone | Investigational New Drugs Targeted Androgen Receptor | Investigational New Drugs Targeted Androgen biosynthesis

Data type

boolean

Alias
UMLS CUI [1]
C2830126
UMLS CUI [2]
C1569219
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0034786
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C1157302
patients who have received antiandrogens such as flutamide (eulexin®), bicalutamide (casodex®), or nilutamide (nilandron®) for > 3 months must be off treatment for 6 weeks and demonstrate a continued rise in psa after withdrawal. patients on antiandrogens for < 3 months must be off medication for 2 weeks. patients on 5 alpha reductase inhibitors such as finasteride (proscar®, propecia®), or dutasteride (avodart®) must stop medication at least 3 months from study entry.
Description

Androgen Antagonists | Flutamide | Eulexin | bicalutamide | Casodex | nilutamide | Nilandron | 5-alpha Reductase Inhibitors To be stopped | Finasteride | Proscar | Propecia | Dutasteride | Avodart

Data type

boolean

Alias
UMLS CUI [1]
C0002842
UMLS CUI [2]
C0016384
UMLS CUI [3]
C0591412
UMLS CUI [4]
C0285590
UMLS CUI [5]
C0591237
UMLS CUI [6]
C0068771
UMLS CUI [7]
C0722107
UMLS CUI [8,1]
C2936788
UMLS CUI [8,2]
C1272691
UMLS CUI [9]
C0060389
UMLS CUI [10]
C0678149
UMLS CUI [11]
C0722858
UMLS CUI [12]
C0754659
UMLS CUI [13]
C1170079
patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within 30 days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
Description

CORTICOSTEROIDS FOR SYSTEMIC USE | Topical steroids allowed | Inhaled steroids allowed | Ophthalmic steroids allowed

Data type

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C2064827
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C2065041
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C2013080
UMLS CUI [4,2]
C0683607
patients who have received palliative radiotherapy within 4 weeks of study entry.
Description

Palliative Radiation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C3898008
patients with a history within the last 3 years of another invasive malignancy.
Description

Cancer Other Invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205281
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Similar models

Eligibility Castration-resistant Prostate Cancer NCT02361086

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adenocarcinoma of prostate
Item
patients must have documented histological or cytological evidence of adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Serum Prostate Specific Antigen Increased
Item
patients must have a minimum serum psa level of >2 ng/ml that is rising based on the prostate cancer working group 2 criteria.
boolean
C1883014 (UMLS CUI [1])
Testosterone measurement Castration Level
Item
patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]).
boolean
C0523912 (UMLS CUI [1,1])
C0007344 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
Orchiectomy | Luteinizing Hormone-releasing Hormone Agonist | LHRH antagonists
Item
patients must have undergone orchiectomy, or have been on lhrh agonists or antagonists, for at least 3 months prior to study entry. patients on lhrh agonists/antagonists must remain on these agents for the duration of the study.
boolean
C0029189 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C0023610 (UMLS CUI [3,1])
C0243076 (UMLS CUI [3,2])
ECOG performance status
Item
patients must have an ecog performance score of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Cytotoxic Chemotherapy Castration-Resistant Prostatic Cancer
Item
patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
boolean
C0677881 (UMLS CUI [1,1])
C3658266 (UMLS CUI [1,2])
Second line Antihormone Therapy | Ketoconazole | Aminoglutethimide | Estrogens High dose
Item
patients who have received second-line antihormonal therapy, including ketoconazole, aminoglutethimide, or high-dose estrogen within 30 days of study entry.
boolean
C1710038 (UMLS CUI [1,1])
C2986607 (UMLS CUI [1,2])
C0022625 (UMLS CUI [2])
C0002555 (UMLS CUI [3])
C0014939 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
sipuleucel-T | Provenge
Item
patients who have completed sipuleucel-t (provenge ®) treatment within 30 days of study entry.
boolean
C1706668 (UMLS CUI [1])
C1135133 (UMLS CUI [2])
TOK-001 | Galeterone | Investigational New Drugs Targeted Androgen Receptor | Investigational New Drugs Targeted Androgen biosynthesis
Item
patients who have received tok-001 (galeterone®) or any other investigational product directed towards the androgen receptor or androgen biosynthesis.
boolean
C2830126 (UMLS CUI [1])
C1569219 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0034786 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C1157302 (UMLS CUI [4,3])
Androgen Antagonists | Flutamide | Eulexin | bicalutamide | Casodex | nilutamide | Nilandron | 5-alpha Reductase Inhibitors To be stopped | Finasteride | Proscar | Propecia | Dutasteride | Avodart
Item
patients who have received antiandrogens such as flutamide (eulexin®), bicalutamide (casodex®), or nilutamide (nilandron®) for > 3 months must be off treatment for 6 weeks and demonstrate a continued rise in psa after withdrawal. patients on antiandrogens for < 3 months must be off medication for 2 weeks. patients on 5 alpha reductase inhibitors such as finasteride (proscar®, propecia®), or dutasteride (avodart®) must stop medication at least 3 months from study entry.
boolean
C0002842 (UMLS CUI [1])
C0016384 (UMLS CUI [2])
C0591412 (UMLS CUI [3])
C0285590 (UMLS CUI [4])
C0591237 (UMLS CUI [5])
C0068771 (UMLS CUI [6])
C0722107 (UMLS CUI [7])
C2936788 (UMLS CUI [8,1])
C1272691 (UMLS CUI [8,2])
C0060389 (UMLS CUI [9])
C0678149 (UMLS CUI [10])
C0722858 (UMLS CUI [11])
C0754659 (UMLS CUI [12])
C1170079 (UMLS CUI [13])
CORTICOSTEROIDS FOR SYSTEMIC USE | Topical steroids allowed | Inhaled steroids allowed | Ophthalmic steroids allowed
Item
patients who require pharmacological or replacement doses of systemic corticosteroids or who have received systemic corticosteroids within 30 days of study entry; use of topical, inhaled or ophthalmic steroids is permitted.
boolean
C3653708 (UMLS CUI [1])
C2064827 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C2065041 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C2013080 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Palliative Radiation Therapy
Item
patients who have received palliative radiotherapy within 4 weeks of study entry.
boolean
C3898008 (UMLS CUI [1])
Cancer Other Invasive
Item
patients with a history within the last 3 years of another invasive malignancy.
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
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