Prostate carcinoma
Item
prior confirmed histological diagnosis of prostatic carcinoma.
boolean
C0600139 (UMLS CUI [1])
Raised prostate specific antigen Quantity | Hormone Therapy | Male Castration | Prostate specific antigen measurement
Item
rising psa while receiving hormonal therapy or after surgical castration defined as 2 sequential increases above a previous lowest reference value within the past 12 months; psa must be at least 4ng/ml at the time of study entry.
boolean
C0178415 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C0007347 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
TNM clinical staging - distant metastases Evidence of | Scan of bone | X-ray | Magnetic Resonance Imaging | Tomography, Spiral Computed
Item
no distant metastases as evidenced by bone scan (+ or - centered x-ray or mri), and spiral thoracoabdominopelvic ct scan.
boolean
C3258247 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0203668 (UMLS CUI [2])
C0034571 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0860888 (UMLS CUI [5])
Male Castration | Antiandrogen therapy To be stopped | Raised prostate specific antigen | Flutamide | bicalutamide
Item
effective castration throughout the study. any prior anti-androgen therapy should be stopped with documented continued elevation of psa 4 weeks after the cessation of flutamide (6 weeks for bicalutamide).
boolean
C0007347 (UMLS CUI [1])
C0279492 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0178415 (UMLS CUI [3])
C0016384 (UMLS CUI [4])
C0285590 (UMLS CUI [5])
Serum testosterone measurement | Disease Progression
Item
serum testosterone levels < 50ng/dl at the time of progression and throughout the study.
boolean
C0428413 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Age
Item
age > or = to 18 years.
boolean
C0001779 (UMLS CUI [1])
CYP2D6 extensive metaboliser status
Item
extensive metabolizer by cyp2d6 genotyping.
boolean
C3888997 (UMLS CUI [1])
Karnofsky Performance Status | Life Expectancy
Item
karnofsky performance status > or = to 70% and life expectancy > 6 months.
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hematologic function | Renal function | Liver function
Item
adequate hematological, renal and liver function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
CYP2D6 poor metaboliser status
Item
poor metabolizers by cyp2d6 genotyping.
boolean
C3888904 (UMLS CUI [1])
Palliative radiotherapy | Chemotherapy | Therapies, Investigational
Item
prior palliative radiotherapy or any prior chemotherapy or experimental therapy.
boolean
C0475092 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Estrogen cancer treatment Quantity | Estramustine cancer treatment Quantity | Therapeutic procedure Discontinued
Item
more than one line of any prior anticancer treatment with estrogen (estrogen or estramustine) if discontinued at least 4 weeks before study entry.
boolean
C0014939 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0014921 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Diphosphonates | Adrenal Cortex Hormones chronic
Item
concomitant administration of biphosphonate or chronic corticosteroids.
boolean
C0012544 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
PROGRESSIVE SYMPTOMS Control Inadequate Pharmaceutical Preparations
Item
presence of progressive symptoms not adequately controlled with non opioid medications
boolean
C0240807 (UMLS CUI [1,1])
C0243148 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Cytochrome P450 2D6 Inhibitors
Item
concomitant use of medications known to be cytochrome p450 2d6 inhibitors as listed in protocol appendice
boolean
C2962190 (UMLS CUI [1])
Malignant Neoplasms | Interval Disease Free of | Skin carcinoma Curative treatment
Item
previous malignancies except if there has been a disease-free interval of at least 5 years and except curatively treated non-melanoma skin cancer
boolean
C0006826 (UMLS CUI [1])
C1272706 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0699893 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
Illness Serious Preventing Therapeutic procedure | Medical condition Preventing Therapeutic procedure
Item
other serious illness or medical condition, which would not permit the patient to be managed according to the protocol.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])