Eligibility Prostate Cancer NCT02037464

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StudyEvent: Eligibility
1. Eligibility Prostate Cancer NCT02037464

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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])

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Eligibility Prostate Cancer NCT02037464