Risk factor
Item
to have at least one of the following three risk factors:
boolean
C0035648 (UMLS CUI [1])
Prostate Cancer stage
Item
tumour classified t3 or t4
boolean
C0280280 (UMLS CUI [1])
Gleason score
Item
gleason score 8-10
boolean
C0332326 (UMLS CUI [1])
PSA measurement
Item
prostate-specific antigen (psa) level > 20
boolean
C0201544 (UMLS CUI [1])
Performance status
Item
performance status score of 0-1.
boolean
C1518965 (UMLS CUI [1])
Informed consent
Item
patients must sign a consent form before the start of the study.
boolean
C0021430 (UMLS CUI [1])
Regional disease
Item
no evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography [cat] scan, magnetic resonance imaging [mri], lymphography) or surgical staging or negative pelvic node dissection.
boolean
C1514819 (UMLS CUI [1])
Distant metastasis
Item
no distant metastasis. these patients must all have a negative bone scan 12 weeks prior to randomization.
boolean
C1269798 (UMLS CUI [1])
Hormonal therapy
Item
hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected.
boolean
C0279025 (UMLS CUI [1])
Malignancy: disease free survival
Item
patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years.
boolean
C0006826 (UMLS CUI [1,1])
C0242793 (UMLS CUI [1,2])
Treatment and follow up
Item
the patient must be available for treatments and follow-up visits.
boolean
C0087111 (UMLS CUI [1])
C1522577 (UMLS CUI [2])
Treatment start date
Item
treatments must start in the three weeks following randomization.
boolean
C3173309 (UMLS CUI [1])
Comorbidity limiting compliance
Item
severe medical or psychiatric problems that could compromise study compliance.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
ALT and AST
Item
chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase > 1.5 times the upper normal limit.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])