ID

31612

Description

Radiotherapy - Adjuvant Versus Early Salvage; ODM derived from: https://clinicaltrials.gov/show/NCT00860652

Link

https://clinicaltrials.gov/show/NCT00860652

Keywords

Versions (1)
  1. 9/12/18 9/12/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 12, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00860652

English

Eligibility Prostate Cancer NCT00860652

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
prior radical prostatectomy (rp) for adenocarcinoma of the prostate.
Description

Radical prostatectomy Adenocarcinoma of prostate

Data type

boolean

Alias
UMLS CUI [1,1]
C0194810
UMLS CUI [1,2]
C0007112
histological confirmation of adenocarcinoma of the prostate with the gleason score reported (radical prostatectomy specimen).
Description

Adenocarcinoma of prostate Gleason score | Specimen from prostate obtained by radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3203027
UMLS CUI [2]
C1292667
patients must have at least one of the following risk factors: 1) positive margins, 2) extraprostatic extension (epe) with or without seminal vesicle involvement (pt3a or pt3b)
Description

Risk factors Quantity | Positive Surgical Margins | Extraprostatic extension | Seminal Vesicles Involvement TNM clinical staging | Seminal Vesicles Involvement Absent TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1709603
UMLS CUI [3]
C1717821
UMLS CUI [4,1]
C0036628
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C3258246
UMLS CUI [5,1]
C0036628
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0332197
UMLS CUI [5,4]
C3258246
capable of starting rt within 4 months of rp (a requirement if randomised to adjuvant rt arm)
Description

Capability Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C1522449
most recent psa ≤ 0.10 ng/ml following rp and prior to randomisation
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
eastern cooperative oncology group (ecog) performance status 0 - 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patient able to adhere to the specified follow-up schedule and complete the quality of life and anxiety/depression self-assessments
Description

Follow-up Adherence | Quality of life Self-Assessment Completion | Depressive disorder Self-Assessment Completion | Anxiety Self-Assessment Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1510802
UMLS CUI [2,1]
C0034380
UMLS CUI [2,2]
C0036591
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C0011581
UMLS CUI [3,2]
C0036591
UMLS CUI [3,3]
C0205197
UMLS CUI [4,1]
C0003467
UMLS CUI [4,2]
C0036591
UMLS CUI [4,3]
C0205197
written informed consent obtained prior to randomisation
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
completion of all pre-treatment evaluations
Description

Evaluation pre treatment Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C2709094
UMLS CUI [1,3]
C0205197
18 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous pelvic rt
Description

Radiotherapy to pelvis

Data type

boolean

Alias
UMLS CUI [1]
C1536155
androgen deprivation (ad) prior to or following rp
Description

Antiandrogen therapy prior to Radical prostatectomy | Antiandrogen therapy Following Radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0194810
UMLS CUI [2,1]
C0279492
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0194810
evidence of nodal or distant metastases
Description

Secondary malignant neoplasm of lymph node | Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0686619
UMLS CUI [2]
C1269798
co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
Description

Comorbidity Interferes with Treatment completion | Comorbidity Interferes with Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0580352
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3274571
concurrent cytotoxic medication
Description

Cytotoxic agent

Data type

boolean

Alias
UMLS CUI [1]
C0304497
hip prosthesis
Description

Hip prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0019560
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Similar models

Eligibility Prostate Cancer NCT00860652

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Radical prostatectomy Adenocarcinoma of prostate
Item
prior radical prostatectomy (rp) for adenocarcinoma of the prostate.
boolean
C0194810 (UMLS CUI [1,1])
C0007112 (UMLS CUI [1,2])
Adenocarcinoma of prostate Gleason score | Specimen from prostate obtained by radical prostatectomy
Item
histological confirmation of adenocarcinoma of the prostate with the gleason score reported (radical prostatectomy specimen).
boolean
C0007112 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
C1292667 (UMLS CUI [2])
Risk factors Quantity | Positive Surgical Margins | Extraprostatic extension | Seminal Vesicles Involvement TNM clinical staging | Seminal Vesicles Involvement Absent TNM clinical staging
Item
patients must have at least one of the following risk factors: 1) positive margins, 2) extraprostatic extension (epe) with or without seminal vesicle involvement (pt3a or pt3b)
boolean
C0035648 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1709603 (UMLS CUI [2])
C1717821 (UMLS CUI [3])
C0036628 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C0036628 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C3258246 (UMLS CUI [5,4])
Capability Therapeutic radiology procedure
Item
capable of starting rt within 4 months of rp (a requirement if randomised to adjuvant rt arm)
boolean
C2698977 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
most recent psa ≤ 0.10 ng/ml following rp and prior to randomisation
boolean
C0201544 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 - 1
boolean
C1520224 (UMLS CUI [1])
Follow-up Adherence | Quality of life Self-Assessment Completion | Depressive disorder Self-Assessment Completion | Anxiety Self-Assessment Completion
Item
patient able to adhere to the specified follow-up schedule and complete the quality of life and anxiety/depression self-assessments
boolean
C3274571 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
C0034380 (UMLS CUI [2,1])
C0036591 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0011581 (UMLS CUI [3,1])
C0036591 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0003467 (UMLS CUI [4,1])
C0036591 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
Informed Consent
Item
written informed consent obtained prior to randomisation
boolean
C0021430 (UMLS CUI [1])
Evaluation pre treatment Completion
Item
completion of all pre-treatment evaluations
boolean
C1261322 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Age
Item
18 years and older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to pelvis
Item
previous pelvic rt
boolean
C1536155 (UMLS CUI [1])
Antiandrogen therapy prior to Radical prostatectomy | Antiandrogen therapy Following Radical prostatectomy
Item
androgen deprivation (ad) prior to or following rp
boolean
C0279492 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0194810 (UMLS CUI [1,3])
C0279492 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
Secondary malignant neoplasm of lymph node | Distant metastasis
Item
evidence of nodal or distant metastases
boolean
C0686619 (UMLS CUI [1])
C1269798 (UMLS CUI [2])
Comorbidity Interferes with Treatment completion | Comorbidity Interferes with Follow-up
Item
co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0580352 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Cytotoxic agent
Item
concurrent cytotoxic medication
boolean
C0304497 (UMLS CUI [1])
Hip prosthesis
Item
hip prosthesis
boolean
C0019560 (UMLS CUI [1])
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