Sorafenib Tosylate and Gene Expression Analysis in Patients Undergoing Surgery For High-Risk Localized Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Stage II Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: sorafenib tosylate; microarray analysis; immunohistochemistry staining method; gene expression analysis; needle biopsy; therapeutic conventional surgery; laboratory biomarker analysis; western blotting; RNA analysis
Intervention description: Given PO; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Undergo prostatectomy; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying sorafenib tosylate and gene expression in patients undergoing
      surgery for high-risk localized prostate cancer. Sorafenib tosylate may stop the growth of
      tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow
      to the tumor. Studying samples of blood and tumor tissues in the laboratory from patients
      with prostate cancer may help doctors learn more about changes that occur in DNA after
      treatment with sorafenib tosylate
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Radical prostatectomy and lymph node dissection planned as primary therapy in a
             patient with acceptable surgical risk (e.g., cardiovascular, pulmonary, and functional
             status)

          -  10 year or longer life expectancy

          -  Any of the following high-risk features: Clinical stage T2b (palpable bilateral
             involvement) OR surgically resectable T3 OR PSA >= 20 ng/ml OR overall Gleason grade
             >= 8

          -  No evidence of bone metastases on bone scan

          -  No evidence of lymph nodes >= 2 cm in diameter on pelvic CT scan

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Hemoglobin >= 9.0 g/dl

          -  Absolute neutrophil count (ANC) >= 1,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Total bilirubin =< 1.5 x ULN

          -  ALT =< 2.5 x the ULN

          -  AST =< 2.5 x the ULN

          -  INR =< 1.5 and aPTT within normal limits

          -  Creatinine =< 1.5 x ULN or creatinine clearance > 60mL/min/1.73 m^2

          -  Men must agree to use adequate contraception (abstinence, hormonal in female partner,
             or barrier method of birth control) prior to study entry, for the duration of study
             participation, and for at least two weeks after stopping treatment

          -  Signed informed patient consent

        Exclusion Criteria:

          -  Prior therapy for prostate cancer including conventional androgen deprivation therapy,
             radiotherapy (external beam or brachytherapy), cryotherapy, and/or cytotoxic
             chemotherapy

          -  Any known metastasis; patients with neurological symptoms must undergo a CT scan/MRI
             of the brain to exclude brain metastasis

          -  Significant active medical illness which in the opinion of the investigator would
             preclude protocol treatment

          -  Another malignancy, other than non-melanoma skin cancer, during the past 5 years

          -  History of bleeding diathesis or unexpected surgical bleeding

          -  Patients with active coagulopathy

          -  Cardiac disease: Congestive heart failure > class II NYHA; patients must not have
             unstable angina (anginal symptoms at rest) or new onset angina (began within the last
             3 months) or myocardial infarction within the past 6 months

          -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

          -  Uncontrolled hypertension, as defined by systolic blood pressure consistently in
             excess of 150 mmHg, or diastolic pressure consistently in excess of 90 mmHg

          -  Thrombolic or embolic events such as a cerebrovascular accident including transient
             ischemic attacks within the past 6 months

          -  Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of
             study drug

          -  Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks of first dose of
             study drug

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to sorafenib

          -  Patients may not be concurrently receiving any chemotherapy, immunotherapy, hormonal
             therapy, or molecular targeted agents to treat their prostate cancer

          -  Patients may not be receiving any other investigational agents

          -  Therapeutic anticoagulation with heparin, low-molecular weight heparin, or warfarin
             within the last 4 weeks

          -  Patients may not be using rifampin, digoxin, quinidine, ketoconazole, itraconazole,
             cyclosporine, carbamazepine, phenytoin, phenobarbital, St. John's Wart, or products
             containing grapefruit juice

          -  Patients may not be using bevacizumab or any other drugs that target VEGF or VEGF
             receptors

          -  Active clinically significant infections (>= grade 2 NCI-CTCAE version 3.0); patients
             may enroll after infection resolves

          -  HIV-positive patients receiving combination anti-retroviral therapy because of
             possible pharmacokinetic interactions with Sorafenib

          -  Any condition that impairs patient's ability to swallow whole pills

          -  Any malabsorption problem