ID

31611

Beschrijving

Radiation Therapy for Rising Prostate Specific Antigen (PSA) Post-prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT00850941

Link

https://clinicaltrials.gov/show/NCT00850941

Trefwoorden

Versies (2)
  1. 12-09-18 12-09-18 -
  2. 12-09-18 12-09-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 september 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00850941

Engels

Eligibility Prostate Cancer NCT00850941

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adenocarcinoma of the prostate definitively treated by radical prostatectomy.
Beschrijving

Adenocarcinoma of prostate | Radical prostatectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C0194810
2. patients must have no evidence of nodal or distant metastasis by clinical and radiologic staging to include bone scan and ct scan or mri of the abdomen and pelvis. patients with clinical or radiographic local recurrence are eligible. in patients with gleason score less than or equal to 7 and psa less than or equal to 1, ct or mri of the abdomen is recommended but not required.
Beschrijving

Secondary malignant neoplasm of lymph node Absent TNM clinical staging | Distant metastasis Absent TNM clinical staging | Abdomen Bone scan | Pelvis Bone scan | CT of abdomen and pelvis | MRI of abdomen and pelvis | Recurrence Local | Gleason score | Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686619
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0000726
UMLS CUI [3,2]
C0203668
UMLS CUI [4,1]
C0030797
UMLS CUI [4,2]
C0203668
UMLS CUI [5]
C1641132
UMLS CUI [6]
C1631605
UMLS CUI [7,1]
C2825055
UMLS CUI [7,2]
C0205276
UMLS CUI [8]
C3203027
UMLS CUI [9]
C0201544
3. rising psa after prostatectomy defined as at least 2 consecutive rises. if total psa < 0.2 ng/ml, surgical pathology must also show extracapsular extension, positive margins, or seminal vesicle involvement.
Beschrijving

Raised prostate specific antigen Post Prostatectomy | Raised prostate specific antigen Quantity | Prostate specific antigen measurement | Extension Extracapsular Surgical pathology | Positive Margins Surgical pathology | Seminal Vesicles Involvement Surgical pathology

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0033573
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0201544
UMLS CUI [4,1]
C0231448
UMLS CUI [4,2]
C1517049
UMLS CUI [4,3]
C0200810
UMLS CUI [5,1]
C1709603
UMLS CUI [5,2]
C0200810
UMLS CUI [6,1]
C0036628
UMLS CUI [6,2]
C1314939
UMLS CUI [6,3]
C0200810
4. total psa < 5 ng/ml within 12 weeks prior to starting radiation or hormone therapy.
Beschrijving

Prostate specific antigen measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
5. patients with psa greater than or equal to 0.5 ng/ml may have up to 3 months of an lhrh agonist and an anti-androgen immediately prior to enrollment.
Beschrijving

Prostate specific antigen measurement | LHRH Agonist | Androgen Antagonists

Datatype

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C1518041
UMLS CUI [3]
C0002842
6. all patient must have a serum testosterone of 150 ng/dl or greater documented prior to initiation of hormone therapy. alternatively, patients without documentation of serum testosterone prior to initiation of hormone therapy should not have had any other prior hormone therapy within the 24 months preceding initiation of hormone therapy.
Beschrijving

Serum testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0428413
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with pathologically positive pelvic lymph nodes at prostatectomy.
Beschrijving

Pelvic lymph nodes Positive | Prostatectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0729595
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0033573
2. patients with positive prostascint scans outside prostatic fossa.
Beschrijving

ProstaScint Scan Positive | Exception Prostate Fossa

Datatype

boolean

Alias
UMLS CUI [1,1]
C2985362
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2983573
3. any chemotherapy, immunotherapy, biological therapy for cancer within 90 days of enrollment.
Beschrijving

Chemotherapy Malignant Neoplasms | Immunotherapy Malignant Neoplasms | Biological treatment Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0006826
4. hormone therapy (specifically lhrh agonist or antagonist, non-steroidal or steroidal antiandrogens) of more than 6 months duration at any time in the past for prostate cancer.
Beschrijving

Hormone Therapy Prostate carcinoma | LHRH Agonist | LHRH antagonists | Nonsteroidal Anti-Androgens | Steroidal antiandrogen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C1518041
UMLS CUI [3,1]
C0023610
UMLS CUI [3,2]
C0243076
UMLS CUI [4]
C1320169
UMLS CUI [5]
C1633739
5. contraindications to external beam radiation therapy to include previous pelvic radiation, inflammatory bowel disease or history of collagen vascular disease.
Beschrijving

Medical contraindication External beam radiotherapy | Radiotherapy to pelvis Included | Inflammatory Bowel Diseases Included | Collagen-vascular disease Included

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0419095
UMLS CUI [2,1]
C1536155
UMLS CUI [2,2]
C0332257
UMLS CUI [3,1]
C0021390
UMLS CUI [3,2]
C0332257
UMLS CUI [4,1]
C0262428
UMLS CUI [4,2]
C0332257
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Similar models

Eligibility Prostate Cancer NCT00850941

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Radical prostatectomy
Item
1. adenocarcinoma of the prostate definitively treated by radical prostatectomy.
boolean
C0007112 (UMLS CUI [1])
C0194810 (UMLS CUI [2])
Secondary malignant neoplasm of lymph node Absent TNM clinical staging | Distant metastasis Absent TNM clinical staging | Abdomen Bone scan | Pelvis Bone scan | CT of abdomen and pelvis | MRI of abdomen and pelvis | Recurrence Local | Gleason score | Prostate specific antigen measurement
Item
2. patients must have no evidence of nodal or distant metastasis by clinical and radiologic staging to include bone scan and ct scan or mri of the abdomen and pelvis. patients with clinical or radiographic local recurrence are eligible. in patients with gleason score less than or equal to 7 and psa less than or equal to 1, ct or mri of the abdomen is recommended but not required.
boolean
C0686619 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0000726 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
C0030797 (UMLS CUI [4,1])
C0203668 (UMLS CUI [4,2])
C1641132 (UMLS CUI [5])
C1631605 (UMLS CUI [6])
C2825055 (UMLS CUI [7,1])
C0205276 (UMLS CUI [7,2])
C3203027 (UMLS CUI [8])
C0201544 (UMLS CUI [9])
Raised prostate specific antigen Post Prostatectomy | Raised prostate specific antigen Quantity | Prostate specific antigen measurement | Extension Extracapsular Surgical pathology | Positive Margins Surgical pathology | Seminal Vesicles Involvement Surgical pathology
Item
3. rising psa after prostatectomy defined as at least 2 consecutive rises. if total psa < 0.2 ng/ml, surgical pathology must also show extracapsular extension, positive margins, or seminal vesicle involvement.
boolean
C0178415 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0033573 (UMLS CUI [1,3])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0201544 (UMLS CUI [3])
C0231448 (UMLS CUI [4,1])
C1517049 (UMLS CUI [4,2])
C0200810 (UMLS CUI [4,3])
C1709603 (UMLS CUI [5,1])
C0200810 (UMLS CUI [5,2])
C0036628 (UMLS CUI [6,1])
C1314939 (UMLS CUI [6,2])
C0200810 (UMLS CUI [6,3])
Prostate specific antigen measurement
Item
4. total psa < 5 ng/ml within 12 weeks prior to starting radiation or hormone therapy.
boolean
C0201544 (UMLS CUI [1])
Prostate specific antigen measurement | LHRH Agonist | Androgen Antagonists
Item
5. patients with psa greater than or equal to 0.5 ng/ml may have up to 3 months of an lhrh agonist and an anti-androgen immediately prior to enrollment.
boolean
C0201544 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
C0002842 (UMLS CUI [3])
Serum testosterone measurement
Item
6. all patient must have a serum testosterone of 150 ng/dl or greater documented prior to initiation of hormone therapy. alternatively, patients without documentation of serum testosterone prior to initiation of hormone therapy should not have had any other prior hormone therapy within the 24 months preceding initiation of hormone therapy.
boolean
C0428413 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pelvic lymph nodes Positive | Prostatectomy
Item
1. patients with pathologically positive pelvic lymph nodes at prostatectomy.
boolean
C0729595 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0033573 (UMLS CUI [2])
ProstaScint Scan Positive | Exception Prostate Fossa
Item
2. patients with positive prostascint scans outside prostatic fossa.
boolean
C2985362 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2983573 (UMLS CUI [2,2])
Chemotherapy Malignant Neoplasms | Immunotherapy Malignant Neoplasms | Biological treatment Malignant Neoplasms
Item
3. any chemotherapy, immunotherapy, biological therapy for cancer within 90 days of enrollment.
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
Hormone Therapy Prostate carcinoma | LHRH Agonist | LHRH antagonists | Nonsteroidal Anti-Androgens | Steroidal antiandrogen
Item
4. hormone therapy (specifically lhrh agonist or antagonist, non-steroidal or steroidal antiandrogens) of more than 6 months duration at any time in the past for prostate cancer.
boolean
C0279025 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1518041 (UMLS CUI [2])
C0023610 (UMLS CUI [3,1])
C0243076 (UMLS CUI [3,2])
C1320169 (UMLS CUI [4])
C1633739 (UMLS CUI [5])
Medical contraindication External beam radiotherapy | Radiotherapy to pelvis Included | Inflammatory Bowel Diseases Included | Collagen-vascular disease Included
Item
5. contraindications to external beam radiation therapy to include previous pelvic radiation, inflammatory bowel disease or history of collagen vascular disease.
boolean
C1301624 (UMLS CUI [1,1])
C0419095 (UMLS CUI [1,2])
C1536155 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C0021390 (UMLS CUI [3,1])
C0332257 (UMLS CUI [3,2])
C0262428 (UMLS CUI [4,1])
C0332257 (UMLS CUI [4,2])
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