ID

13618

Description

Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c; ODM derived from: https://clinicaltrials.gov/show/NCT00817739

Link

https://clinicaltrials.gov/show/NCT00817739

Keywords

Versions (1)
  1. 2/20/16 2/20/16 -
Uploaded on

February 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasms NCT00817739

English

Eligibility Prostatic Neoplasms NCT00817739

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed metastatic cancer of the prostate (stage d2 or tx nx m1 ≠ m1a)
Description

prostate cancer, metastastic disease, tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C0027627
UMLS CUI [3]
C1300072
with measurable bone or visceral (lung, liver, etc.) metastases (radiographic conformation was necessary in the event of a questionable bone scan detection in conjunction with only slightly elevated psa levels [at least 20 ng/ml or less than or equal to 50 ng/ml]). the prostatic carcinoma could have been diagnosed at an earlier stage and treated without castration.
Description

measurable metastases, psa levels

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C1513041
UMLS CUI [3]
C0138741
pre-assessment psa 5-fold or higher than the standard level set by the central laboratory, that is, psa greater than or equal to (≥) 20 ng/ml as quantitated by the hybritech radioimmunoassay (normal is less than [<] 4 ng/ml).
Description

pre-assessment psa

Data type

boolean

Alias
UMLS CUI [1]
C0138741
ecog performance status of no more than 2.
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
normal testosterone levels according to the central laboratory standards.
Description

testosterone level

Data type

boolean

Alias
UMLS CUI [1]
C0039601
aspartate transaminase (ast) and alanine transaminase (alt) < 2.25-fold higher than the standard levels set by the central laboratory (except when liver metastases were present).
Description

Ast and alt

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
anticipated life expectancy greater than 9 months.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
written informed consent given to participate and collaborate in the study. inclusion criteria for continuous or intermittent treatment phase
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects who meet the pre-assessment criteria and who has psa < 4 ng/ml after 6 months of induction therapy.
Description

meets inclusion criteria, psa levels

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0138741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject refuse to sign the informed consent form or is likely to be uncooperative or not to comply with the obligations set out in the study protocol.
Description

refuse to sign the informed consent, compliance limited

Data type

boolean

Alias
UMLS CUI [1]
C1321605
subject has received prior hormonal (and neoadjuvant) treatment prompting medical castration (estrogens, hormone-releasing hormone agonists, androgens) or has undergone surgical castration.
Description

prior therapy resulting in castration

Data type

boolean

Alias
UMLS CUI [1]
C0007344
UMLS CUI [2]
C0455189
UMLS CUI [3]
C1514463
subject has undergone bilateral suprarenalectomy or hypophysectomy.
Description

bilateral suprarenalectomy or hypophysectomy

Data type

boolean

Alias
UMLS CUI [1]
C0020632
UMLS CUI [2]
C0193667
subject had another cancer (except basiloma) with the past 5 years.
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
subject has serious unstable progressive disease (renal, hepatic, cardiovascular, psychological, etc).
Description

serious unstable progressive disease

Data type

boolean

Alias
UMLS CUI [1]
C0009488
subject is receiving or has received another experimental treatment within 3 months prior to inclusion.
Description

prior experimental therapy

Data type

boolean

Alias
UMLS CUI [1]
C0949266
exclusion criteria for continuous or intermittent treatment phase
Description

exclusion criteria for continuous or intermittent treatment phase

Data type

boolean

Alias
UMLS CUI [1]
C0680251
subjects who met the pre-assessment criteria and who, after 6 months of induction therapy, had psa ≥ 4 ng/ml and/or on-treatment signs of disease progression.
Description

pre-assessment criteria met, psa levels too high

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0138741
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Similar models

Eligibility Prostatic Neoplasms NCT00817739

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
prostate cancer, metastastic disease, tumor stage
Item
histologically confirmed metastatic cancer of the prostate (stage d2 or tx nx m1 ≠ m1a)
boolean
C0600139 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C1300072 (UMLS CUI [3])
measurable metastases, psa levels
Item
with measurable bone or visceral (lung, liver, etc.) metastases (radiographic conformation was necessary in the event of a questionable bone scan detection in conjunction with only slightly elevated psa levels [at least 20 ng/ml or less than or equal to 50 ng/ml]). the prostatic carcinoma could have been diagnosed at an earlier stage and treated without castration.
boolean
C0027627 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C0138741 (UMLS CUI [3])
pre-assessment psa
Item
pre-assessment psa 5-fold or higher than the standard level set by the central laboratory, that is, psa greater than or equal to (≥) 20 ng/ml as quantitated by the hybritech radioimmunoassay (normal is less than [<] 4 ng/ml).
boolean
C0138741 (UMLS CUI [1])
performance status
Item
ecog performance status of no more than 2.
boolean
C1520224 (UMLS CUI [1])
testosterone level
Item
normal testosterone levels according to the central laboratory standards.
boolean
C0039601 (UMLS CUI [1])
Ast and alt
Item
aspartate transaminase (ast) and alanine transaminase (alt) < 2.25-fold higher than the standard levels set by the central laboratory (except when liver metastases were present).
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
life expectancy
Item
anticipated life expectancy greater than 9 months.
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
written informed consent given to participate and collaborate in the study. inclusion criteria for continuous or intermittent treatment phase
boolean
C0021430 (UMLS CUI [1])
meets inclusion criteria, psa levels
Item
subjects who meet the pre-assessment criteria and who has psa < 4 ng/ml after 6 months of induction therapy.
boolean
C1512693 (UMLS CUI [1])
C0138741 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
refuse to sign the informed consent, compliance limited
Item
subject refuse to sign the informed consent form or is likely to be uncooperative or not to comply with the obligations set out in the study protocol.
boolean
C1321605 (UMLS CUI [1])
prior therapy resulting in castration
Item
subject has received prior hormonal (and neoadjuvant) treatment prompting medical castration (estrogens, hormone-releasing hormone agonists, androgens) or has undergone surgical castration.
boolean
C0007344 (UMLS CUI [1])
C0455189 (UMLS CUI [2])
C1514463 (UMLS CUI [3])
bilateral suprarenalectomy or hypophysectomy
Item
subject has undergone bilateral suprarenalectomy or hypophysectomy.
boolean
C0020632 (UMLS CUI [1])
C0193667 (UMLS CUI [2])
malignancies
Item
subject had another cancer (except basiloma) with the past 5 years.
boolean
C0006826 (UMLS CUI [1])
serious unstable progressive disease
Item
subject has serious unstable progressive disease (renal, hepatic, cardiovascular, psychological, etc).
boolean
C0009488 (UMLS CUI [1])
prior experimental therapy
Item
subject is receiving or has received another experimental treatment within 3 months prior to inclusion.
boolean
C0949266 (UMLS CUI [1])
exclusion criteria for continuous or intermittent treatment phase
Item
exclusion criteria for continuous or intermittent treatment phase
boolean
C0680251 (UMLS CUI [1])
pre-assessment criteria met, psa levels too high
Item
subjects who met the pre-assessment criteria and who, after 6 months of induction therapy, had psa ≥ 4 ng/ml and/or on-treatment signs of disease progression.
boolean
C1512693 (UMLS CUI [1])
C0138741 (UMLS CUI [2])
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