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])
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])