ID

13875

Description

Pre-Prostatectomy Lovastatin on Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01478828

Link

https://clinicaltrials.gov/show/NCT01478828

Keywords

Versions (1)
  1. 3/13/16 3/13/16 -
Uploaded on

March 13, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT01478828

English

Eligibility Prostate Cancer NCT01478828

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs, stage t1c or higher.
Description

Adenocarcinoma of prostate; Tumor stage; lymph nodes; bone

Data type

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2]
C1300072
UMLS CUI [3]
C0024204
UMLS CUI [4]
C0262950
2. tumor gleason sum of 7 (4+3 and 3+4 allowed) in at least one core, after central review of prostate biopsy at johns hopkins. however, in accordance with standard clinical practices, adenocarcinoma must be present in at least two discrete biopsy sections ( may vary in gleason score).
Description

gleason score; prostate biopsy; adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C3203027
UMLS CUI [2]
C0194804
UMLS CUI [3]
C0001418
3. age ≥18 years of age.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. radical prostatectomy scheduled at johns hopkins.
Description

radical prostatectomy

Data type

boolean

Alias
UMLS CUI [1]
C0194810
5. willingness to sign and ability to understand informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. no history of treatment with any statin-class medication within 6 months of entry into the trial.
Description

medication statin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0360714
7. ecog (eastern cooperative oncology group) performance status 0-1.
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
8. adequate bone marrow, hepatic, and renal function as determined by:
Description

bone marrow function; hepatic function; renal function

Data type

boolean

Alias
UMLS CUI [1]
C0412480
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
wbc (white blood cells) >3,500 cells/mm3 anc (absolute neutrophil count) >1,500 cells/mm3 hemoglobin >9 g/dl platelet count >100,000 cells/mm3 serum creatinine < 2.6 mg/dl serum bilirubin <2 mg/dl alt (alanine aminotransferase), ast (aspartate aminotransferase), and alkaline phosphatase <2 times the upper limit of normal triglycerides and total cholesterol <3 times the upper limit of normal
Description

white blood cells; absolute neutrophil count; platelets; hemoglobin; serum bilirubin; Alanine aminotransferase; aspartate aminotransferase; serum creatinine; alkaline phosphatase; total cholesterol; triglycerides

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0428441
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201976
UMLS CUI [9]
C0002059
UMLS CUI [10]
C0543421
UMLS CUI [11]
C0202236
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with evidence of metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases.
Description

metastatic prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C0936223
2. other histologic prostate cancers, including ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors.
Description

prostate cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0600139
3. uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy including active liver disease, unexplained persistent elevation of serum transaminases, or medications that interfere with the metabolism of lovastatin, or gastrointestinal disease that would limit the ability to swallow or take oral medications or absorb them.
Description

Compliance behavior Limited Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
4. concurrent malignancy other than prostate cancer.
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
5. inability to provide informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. concomitant use of azole antifungals, cyclosporine, clarithromycin, erythromycin, fibric acid derivatives, lopinavir/ritonavir, niacin, ritonavir/saquinavir
Description

concomitant medication antifungals cyclosporine

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0003308
UMLS CUI [1,3]
C0010592
7. prior chemotherapy, radiation therapy, biologic therapy, or immunotherapy for prostate cancer.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
8. poor performance status (ecog >1).
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
9. prostatectomy at other hospital other than johns hopkins.
Description

prostatectomy

Data type

boolean

Alias
UMLS CUI [1]
C0033573
10. prior history of allergy or severe reaction to statins or statin derivatives.
Description

hypersensitivity statin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0360714
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Similar models

Eligibility Prostate Cancer NCT01478828

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate; Tumor stage; lymph nodes; bone
Item
1. adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs, stage t1c or higher.
boolean
C0007112 (UMLS CUI [1])
C1300072 (UMLS CUI [2])
C0024204 (UMLS CUI [3])
C0262950 (UMLS CUI [4])
gleason score; prostate biopsy; adenocarcinoma
Item
2. tumor gleason sum of 7 (4+3 and 3+4 allowed) in at least one core, after central review of prostate biopsy at johns hopkins. however, in accordance with standard clinical practices, adenocarcinoma must be present in at least two discrete biopsy sections ( may vary in gleason score).
boolean
C3203027 (UMLS CUI [1])
C0194804 (UMLS CUI [2])
C0001418 (UMLS CUI [3])
age
Item
3. age ≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
radical prostatectomy
Item
4. radical prostatectomy scheduled at johns hopkins.
boolean
C0194810 (UMLS CUI [1])
informed consent
Item
5. willingness to sign and ability to understand informed consent.
boolean
C0021430 (UMLS CUI [1])
medication statin
Item
6. no history of treatment with any statin-class medication within 6 months of entry into the trial.
boolean
C0013227 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
ecog performance status
Item
7. ecog (eastern cooperative oncology group) performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
bone marrow function; hepatic function; renal function
Item
8. adequate bone marrow, hepatic, and renal function as determined by:
boolean
C0412480 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
white blood cells; absolute neutrophil count; platelets; hemoglobin; serum bilirubin; Alanine aminotransferase; aspartate aminotransferase; serum creatinine; alkaline phosphatase; total cholesterol; triglycerides
Item
wbc (white blood cells) >3,500 cells/mm3 anc (absolute neutrophil count) >1,500 cells/mm3 hemoglobin >9 g/dl platelet count >100,000 cells/mm3 serum creatinine < 2.6 mg/dl serum bilirubin <2 mg/dl alt (alanine aminotransferase), ast (aspartate aminotransferase), and alkaline phosphatase <2 times the upper limit of normal triglycerides and total cholesterol <3 times the upper limit of normal
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0428441 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C0002059 (UMLS CUI [9])
C0543421 (UMLS CUI [10])
C0202236 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
metastatic prostate cancer
Item
1. patients with evidence of metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases.
boolean
C0936223 (UMLS CUI [1])
prostate cancer
Item
2. other histologic prostate cancers, including ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors.
boolean
C0019638 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Compliance behavior Limited Comorbidity
Item
3. uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy including active liver disease, unexplained persistent elevation of serum transaminases, or medications that interfere with the metabolism of lovastatin, or gastrointestinal disease that would limit the ability to swallow or take oral medications or absorb them.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
malignancy
Item
4. concurrent malignancy other than prostate cancer.
boolean
C0006826 (UMLS CUI [1])
informed consent
Item
5. inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
concomitant medication antifungals cyclosporine
Item
6. concomitant use of azole antifungals, cyclosporine, clarithromycin, erythromycin, fibric acid derivatives, lopinavir/ritonavir, niacin, ritonavir/saquinavir
boolean
C2347852 (UMLS CUI [1,1])
C0003308 (UMLS CUI [1,2])
C0010592 (UMLS CUI [1,3])
Study Subject Participation Status
Item
7. prior chemotherapy, radiation therapy, biologic therapy, or immunotherapy for prostate cancer.
boolean
C2348568 (UMLS CUI [1])
ecog performance status
Item
8. poor performance status (ecog >1).
boolean
C1520224 (UMLS CUI [1])
prostatectomy
Item
9. prostatectomy at other hospital other than johns hopkins.
boolean
C0033573 (UMLS CUI [1])
hypersensitivity statin
Item
10. prior history of allergy or severe reaction to statins or statin derivatives.
boolean
C0020517 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
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