ID

31593

Description

Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00736645

Link

https://clinicaltrials.gov/show/NCT00736645

Keywords

Versions (1)
  1. 9/10/18 9/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 10, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00736645

English

Eligibility Prostate Cancer NCT00736645

1 forms  
Criteria
Description

Criteria

histologically proven adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0007112
diagnosed by sextant or greater biopsy
Description

Diagnosis Sextant biopsy | Diagnosis Biopsy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C3846092
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C1265611
clinical stage < t3 (stage i or ii) disease
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
prostate-specific antigen < 20.0 ng/ml
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
gleason score < 8
Description

Gleason score

Data type

boolean

Alias
UMLS CUI [1]
C3203027
scheduled to undergo prostatectomy or brachytherapy
Description

Prostatectomy Scheduled | Brachytherapy Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0033573
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0006098
UMLS CUI [2,2]
C0205539
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
life expectancy > 5 years
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
no other prior malignancy (excluding nonmelanoma skin cancer) in the past 5 years
Description

Exclusion | Cancer Other | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
willing and able to take finasteride, selenomethionine, and/or placebo for 3-5 weeks prior to prostatectomy/brachytherapy
Description

Finasteride | Selenomethionine | Placebo

Data type

boolean

Alias
UMLS CUI [1]
C0060389
UMLS CUI [2]
C0036584
UMLS CUI [3]
C1696465
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
more than 1 year since prior finasteride, dutasteride, sereona repens (saw palmetto), or any other 5-α reductase inhibitor
Description

Finasteride Previous | Dutasteride Previous | Serenoa repens extract Previous | Saw palmetto extract Previous | 5-alpha Reductase Inhibitors Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0060389
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0754659
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C3491902
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C0771607
UMLS CUI [4,2]
C0205156
UMLS CUI [5,1]
C2936788
UMLS CUI [5,2]
C0205156
no prior hormonal therapy or radiotherapy
Description

Exclusion Criteria | Hormone Therapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
more than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modification or exercise)
Description

Exclusion Criteria | Study Subject Participation Status Involving Therapeutic intervention | Study Subject Participation Status Involving Surgical intervention | Study Subject Participation Status Involving Nutritional Intervention | Study Subject Participation Status Involving Life Style Intervention | Dietary Modification | Exercise

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0549433
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C1882127
UMLS CUI [5,1]
C2348568
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0023676
UMLS CUI [5,4]
C0184661
UMLS CUI [6]
C0086153
UMLS CUI [7]
C0015259
no concurrent selenium dietary supplement at doses > 200 mg/day, including multivitamin supplements
Description

Exclusion Criteria | Selenium supplement Dose U/day | Multivitamin Supplements

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0521939
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0301532
UMLS CUI [3,2]
C0242295
at least 30 days since > 200mg/day of prior selenium dietary supplement
Description

Selenium supplement Previous U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0521939
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0456683
no other concurrent hormonal therapy, including 5-α reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)
Description

Exclusion Criteria | Hormone Therapy | 5-alpha Reductase Inhibitors | Finasteride | Dutasteride | Androgen Antagonists | bicalutamide | Flutamide | Ketoconazole | Luteinizing Hormone-releasing Hormone Agonist | Leuprolide Acetate | Goserelin Acetate | abarelix

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0279025
UMLS CUI [3]
C2936788
UMLS CUI [4]
C0060389
UMLS CUI [5]
C0754659
UMLS CUI [6]
C0002842
UMLS CUI [7]
C0285590
UMLS CUI [8]
C0016384
UMLS CUI [9]
C0022625
UMLS CUI [10]
C1518041
UMLS CUI [11]
C0700596
UMLS CUI [12]
C0700476
UMLS CUI [13]
C0965390
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Similar models

Eligibility Prostate Cancer NCT00736645

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adenocarcinoma of prostate
Item
histologically proven adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Diagnosis Sextant biopsy | Diagnosis Biopsy Quantity
Item
diagnosed by sextant or greater biopsy
boolean
C0011900 (UMLS CUI [1,1])
C3846092 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Disease TNM clinical staging
Item
clinical stage < t3 (stage i or ii) disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
prostate-specific antigen < 20.0 ng/ml
boolean
C0201544 (UMLS CUI [1])
Gleason score
Item
gleason score < 8
boolean
C3203027 (UMLS CUI [1])
Prostatectomy Scheduled | Brachytherapy Scheduled
Item
scheduled to undergo prostatectomy or brachytherapy
boolean
C0033573 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0006098 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 5 years
boolean
C0023671 (UMLS CUI [1])
Exclusion | Cancer Other | Exception Skin carcinoma
Item
no other prior malignancy (excluding nonmelanoma skin cancer) in the past 5 years
boolean
C2828389 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
Finasteride | Selenomethionine | Placebo
Item
willing and able to take finasteride, selenomethionine, and/or placebo for 3-5 weeks prior to prostatectomy/brachytherapy
boolean
C0060389 (UMLS CUI [1])
C0036584 (UMLS CUI [2])
C1696465 (UMLS CUI [3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Finasteride Previous | Dutasteride Previous | Serenoa repens extract Previous | Saw palmetto extract Previous | 5-alpha Reductase Inhibitors Previous
Item
more than 1 year since prior finasteride, dutasteride, sereona repens (saw palmetto), or any other 5-α reductase inhibitor
boolean
C0060389 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0754659 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C3491902 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0771607 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C2936788 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
Exclusion Criteria | Hormone Therapy | Therapeutic radiology procedure
Item
no prior hormonal therapy or radiotherapy
boolean
C0680251 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Exclusion Criteria | Study Subject Participation Status Involving Therapeutic intervention | Study Subject Participation Status Involving Surgical intervention | Study Subject Participation Status Involving Nutritional Intervention | Study Subject Participation Status Involving Life Style Intervention | Dietary Modification | Exercise
Item
more than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modification or exercise)
boolean
C0680251 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C2348568 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0549433 (UMLS CUI [3,3])
C2348568 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C1882127 (UMLS CUI [4,3])
C2348568 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0023676 (UMLS CUI [5,3])
C0184661 (UMLS CUI [5,4])
C0086153 (UMLS CUI [6])
C0015259 (UMLS CUI [7])
Exclusion Criteria | Selenium supplement Dose U/day | Multivitamin Supplements
Item
no concurrent selenium dietary supplement at doses > 200 mg/day, including multivitamin supplements
boolean
C0680251 (UMLS CUI [1])
C0521939 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0301532 (UMLS CUI [3,1])
C0242295 (UMLS CUI [3,2])
Selenium supplement Previous U/day
Item
at least 30 days since > 200mg/day of prior selenium dietary supplement
boolean
C0521939 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Exclusion Criteria | Hormone Therapy | 5-alpha Reductase Inhibitors | Finasteride | Dutasteride | Androgen Antagonists | bicalutamide | Flutamide | Ketoconazole | Luteinizing Hormone-releasing Hormone Agonist | Leuprolide Acetate | Goserelin Acetate | abarelix
Item
no other concurrent hormonal therapy, including 5-α reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)
boolean
C0680251 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C2936788 (UMLS CUI [3])
C0060389 (UMLS CUI [4])
C0754659 (UMLS CUI [5])
C0002842 (UMLS CUI [6])
C0285590 (UMLS CUI [7])
C0016384 (UMLS CUI [8])
C0022625 (UMLS CUI [9])
C1518041 (UMLS CUI [10])
C0700596 (UMLS CUI [11])
C0700476 (UMLS CUI [12])
C0965390 (UMLS CUI [13])
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