Age
Item
1. subject is >19 years of age
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
2. subject has a histologically documented diagnosis of prostate adenocarcinoma
boolean
C0007112 (UMLS CUI [1])
Monitoring Surveillance Risk Prostate carcinoma
Item
3. being monitored by active surveillance (see table 1) for favourable risk prostate cancer as defined by the following:
boolean
C0030695 (UMLS CUI [1,1])
C0220920 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
TNM clinical staging
Item
1. clinical stage t1b, t1c, t2a or t2b at the time of diagnosis
boolean
C3258246 (UMLS CUI [1])
Gleason score
Item
2. clinical (diagnostic biopsy) gleason score < 6
boolean
C3203027 (UMLS CUI [1])
Prostate specific antigen measurement
Item
3. psa < 10.0 ng/ml (ug/l)
boolean
C0201544 (UMLS CUI [1])
Tumor tissue sample Biopsy of prostate | Tumor tissue sample Unstained slide Quantity | Determination Ki-67 Expression | Determination p27 Expression
Item
4. tumour material from most recent prostate biopsy available with sample (up to 10 unstained slides) collected for determination of ki67 and p27 biomarker expression.
boolean
C0475358 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C0475358 (UMLS CUI [2,1])
C1883469 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0521095 (UMLS CUI [3,1])
C0208804 (UMLS CUI [3,2])
C0017262 (UMLS CUI [3,3])
C0521095 (UMLS CUI [4,1])
C0971007 (UMLS CUI [4,2])
C0017262 (UMLS CUI [4,3])
Transrectal ultrasound Scheduled
Item
5. scheduled to have an active surveillance mandated transrectal ultrasound (trus) guided biopsy within 6 - 12 months of day 1 of the study
boolean
C0373345 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin
Item
1. previous malignancy (not including curatively treated basal or squamous cell carcinoma of the skin) within the previous 5 years. (ta bladder cancer with negative surveillance cystoscopy within the past 2 years may be included.)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
Therapeutic procedure Prostate carcinoma | Intervention Prostate carcinoma | Exception Biopsy
Item
2. no previous or current treatment (medical therapy or radical intervention) for prostate cancer excluding biopsy
boolean
C0087111 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Transrectal ultrasound Receive Unable
Item
3. inability to undergo trus biopsy
boolean
C0373345 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Pharmaceutical Preparations Excluded
Item
4. concurrent administration of the following medications is not permitted during the protocol:
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
5-alpha Reductase Inhibitors
Item
5 α-reductase inhibitors
boolean
C2936788 (UMLS CUI [1])
Cytotoxic Chemotherapy
Item
cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1])
Immunotherapy
Item
immunotherapy
boolean
C0021083 (UMLS CUI [1])
Hormone Therapy | Megestrol | Medroxyprogesterone | Cyproterone | Diethylstilbestrol | Hydrocortisone
Item
hormonal therapy (megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol, hyrodcortisone, etc.)
boolean
C0279025 (UMLS CUI [1])
C0025175 (UMLS CUI [2])
C0025147 (UMLS CUI [3])
C0010621 (UMLS CUI [4])
C0012203 (UMLS CUI [5])
C0020268 (UMLS CUI [6])
Nonsteroidal Anti-Androgens | bicalutamide | nilutamide | Flutamide
Item
non-steroidal anti-androgens (bicalutamide, nilutamide, flutamide, etc.)
boolean
C1320169 (UMLS CUI [1])
C0285590 (UMLS CUI [2])
C0068771 (UMLS CUI [3])
C0016384 (UMLS CUI [4])
LHRH Analogue | Leuprolide | Goserelin
Item
luteinizing hormone releasing hormone (lhrh) analogues (leuprolide, goserelin, etc.)
boolean
C1518041 (UMLS CUI [1])
C0085272 (UMLS CUI [2])
C0120107 (UMLS CUI [3])
Ketoconazole
Item
ketoconazole
boolean
C0022625 (UMLS CUI [1])
PC-SPES | Pharmaceutical Preparations Endocrine effects
Item
pc-spes and any other preparations thought to have endocrine effects
boolean
C0756934 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0678896 (UMLS CUI [2,2])
Anticholesteremic Agents
Item
medications which inhibit cholesterogenesis ('statin' medications, etc.)
boolean
C0003277 (UMLS CUI [1])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status > 2
boolean
C1520224 (UMLS CUI [1])
Liver disease | Elevated total bilirubin | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
6. known or history of liver disease (total bilirubin, alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 2.5 upper limit of normal at screening visit)
boolean
C0023895 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Life Expectancy Minimum
Item
7. subject has a minimum life expectancy of < 5 years
boolean
C0023671 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Informed Consent Unable
Item
8. subject is unable to give written and informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])