ID

15598

Beskrivning

Provenge (TM) for the Treatment of Hormone Sensitive Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00779402

Länk

https://clinicaltrials.gov/show/NCT00779402

Nyckelord

Versioner (1)
  1. 2016-06-04 2016-06-04 -
Uppladdad den

4 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00779402

Engelsk

Eligibility Prostate Cancer NCT00779402

1 Formulär  
Criteria
Beskrivning

Criteria

histologic diagnosis of adenocarcinoma of the prostate;
Beskrivning

adenocarcinoma of the prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0600139
at least 3 months but no more than 8 years prior to study entry, undergone a radical prostatectomy for stage t1b – t3c, n0-n1, m0 disease, with or without subsequent adjuvant or salvage radiation therapy. patients who experience their first psa recurrence within 2 years post completion of initial therapy of curative intent are eligible without consideration of the gleason score of the tumor specimen.* patients who experience their first psa relapse between 2 and 8 years post completion of initial therapy of curative intent are eligible only if the gleason score of the tumor specimen was > 7; (* for patients who received adjuvant radiation, the date of the final dose of radiotherapy is used to mark the date of completion of therapy of curative intent. for patients who received salvage radiation for post-operative psa recurrence but no adjuvant radiation, the date of surgery marks the date of completion of therapy of curative intent.)
Beskrivning

radical prostatectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0194810
therapeutic psa response to primary therapy below 0.4 ng/ml;
Beskrivning

therapeutic psa response

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0138741
tumor specimen positive for pap, the vaccine’s target. immunohistological staining of a specimen from the surgically excised tumor for expression of pap is conducted by impath, and may be completed even after lh-rh-analogue placement, as long as a positive (+) result is confirmed prior to randomization (week 0). if a slide of the tumor cannot be obtained from the pathology archive, a chart record from a pre-surgery blood sample showing serum pap elevated above the upper limit of the local reference range may serve as a proxy.
Beskrivning

positive for pap

Datatyp

boolean

Alias
UMLS CUI [1]
C0523444
experienced psa relapse while not currently receiving androgen ablation therapy. specifically, on record must be 2 psa values separated by at least 3 months, both in the detectable range (>0.5 ng/ml), showing an increase of at least 0.3 ng/ml between the 2 measurements. the first of these 2 psa values must rise above a previously recorded post-operative nadir value (which may be an undetectable psa). in patients who received androgen ablation for a previous psa relapse, psa must have increased to a level at least 25% above the nadir observed while on this therapy and to an absolute level of at least 3 ng/ml;
Beskrivning

psa relapse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C0035020
prior hormone treatment for an earlier episode of psa relapse is neither an exclusion nor an inclusion requirement for study entry. patients who have previously been treated with adjuvant or salvage radiation following radical prostatectomy, or with either lh-rh-analogue (i.e., leuprolide or goserelin acetate) or non-steroidal anti-androgen therapy (i.e., bicalutamide 150 mg/day) for a prior psa relapse, may enter the study provided:
Beskrivning

hormone treatment for an earlier episode of psa relapse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0138741
UMLS CUI [1,3]
C0035020
post-prostatectomy psa was never > 20 ng/ml;
Beskrivning

post-prostatectomy psa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0138741
UMLS CUI [1,2]
C2062400
psa was not rising while receiving adequately dosed hormonal therapy;
Beskrivning

ID.8

Datatyp

boolean

for any hormonal therapy received, the last effective day of androgen deprivation was at least 6 months prior to study entry;
Beskrivning

androgen deprivation

Datatyp

boolean

Alias
UMLS CUI [1]
C0279492
confirmed m0; a bone scan with no evidence of osseous metastasis must be on record, dated within 6 months prior to entry into the study;
Beskrivning

no evidence of osseous metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0153690
estimated life-expectancy, inclusive consideration of co-morbidities, of at least 1 year;
Beskrivning

life-expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status of 0 or 1;
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
ability to understand the trial procedures and requirements;
Beskrivning

ability to understand

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
age >18 and < 80 years;
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ability to understand, and willingness to sign, informed consent.
Beskrivning

ability to understand informend consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1273101
UMLS CUI [1,2]
C0021430
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Similar models

Eligibility Prostate Cancer NCT00779402

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
adenocarcinoma of the prostate
Item
histologic diagnosis of adenocarcinoma of the prostate;
boolean
C0600139 (UMLS CUI [1])
radical prostatectomy
Item
at least 3 months but no more than 8 years prior to study entry, undergone a radical prostatectomy for stage t1b – t3c, n0-n1, m0 disease, with or without subsequent adjuvant or salvage radiation therapy. patients who experience their first psa recurrence within 2 years post completion of initial therapy of curative intent are eligible without consideration of the gleason score of the tumor specimen.* patients who experience their first psa relapse between 2 and 8 years post completion of initial therapy of curative intent are eligible only if the gleason score of the tumor specimen was > 7; (* for patients who received adjuvant radiation, the date of the final dose of radiotherapy is used to mark the date of completion of therapy of curative intent. for patients who received salvage radiation for post-operative psa recurrence but no adjuvant radiation, the date of surgery marks the date of completion of therapy of curative intent.)
boolean
C0194810 (UMLS CUI [1])
therapeutic psa response
Item
therapeutic psa response to primary therapy below 0.4 ng/ml;
boolean
C0521982 (UMLS CUI [1,1])
C0138741 (UMLS CUI [1,2])
positive for pap
Item
tumor specimen positive for pap, the vaccine’s target. immunohistological staining of a specimen from the surgically excised tumor for expression of pap is conducted by impath, and may be completed even after lh-rh-analogue placement, as long as a positive (+) result is confirmed prior to randomization (week 0). if a slide of the tumor cannot be obtained from the pathology archive, a chart record from a pre-surgery blood sample showing serum pap elevated above the upper limit of the local reference range may serve as a proxy.
boolean
C0523444 (UMLS CUI [1])
psa relapse
Item
experienced psa relapse while not currently receiving androgen ablation therapy. specifically, on record must be 2 psa values separated by at least 3 months, both in the detectable range (>0.5 ng/ml), showing an increase of at least 0.3 ng/ml between the 2 measurements. the first of these 2 psa values must rise above a previously recorded post-operative nadir value (which may be an undetectable psa). in patients who received androgen ablation for a previous psa relapse, psa must have increased to a level at least 25% above the nadir observed while on this therapy and to an absolute level of at least 3 ng/ml;
boolean
C0138741 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
hormone treatment for an earlier episode of psa relapse
Item
prior hormone treatment for an earlier episode of psa relapse is neither an exclusion nor an inclusion requirement for study entry. patients who have previously been treated with adjuvant or salvage radiation following radical prostatectomy, or with either lh-rh-analogue (i.e., leuprolide or goserelin acetate) or non-steroidal anti-androgen therapy (i.e., bicalutamide 150 mg/day) for a prior psa relapse, may enter the study provided:
boolean
C0279025 (UMLS CUI [1,1])
C0138741 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
post-prostatectomy psa
Item
post-prostatectomy psa was never > 20 ng/ml;
boolean
C0138741 (UMLS CUI [1,1])
C2062400 (UMLS CUI [1,2])
ID.8
Item
psa was not rising while receiving adequately dosed hormonal therapy;
boolean
androgen deprivation
Item
for any hormonal therapy received, the last effective day of androgen deprivation was at least 6 months prior to study entry;
boolean
C0279492 (UMLS CUI [1])
no evidence of osseous metastasis
Item
confirmed m0; a bone scan with no evidence of osseous metastasis must be on record, dated within 6 months prior to entry into the study;
boolean
C0153690 (UMLS CUI [1])
life-expectancy
Item
estimated life-expectancy, inclusive consideration of co-morbidities, of at least 1 year;
boolean
C0023671 (UMLS CUI [1])
ecog
Item
ecog performance status of 0 or 1;
boolean
C1520224 (UMLS CUI [1])
ability to understand
Item
ability to understand the trial procedures and requirements;
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
age
Item
age >18 and < 80 years;
boolean
C0001779 (UMLS CUI [1])
ability to understand informend consent
Item
ability to understand, and willingness to sign, informed consent.
boolean
C1273101 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
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