Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Condition: Prostate Cancer; Prostatectomy
MeSH terms: Prostatic Neoplasms
Intervention: Sunitinib Malate
Intervention description: Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to look at blood and tissue samples for changes following the
      use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib
      malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as
      Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors
      of intestines and kidney but it is being tested in research studies for use in men with
      prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative
             RRP

          -  Intermediate or high risk, clinically localized disease

          -  Adequate organ function

          -  Patients must be surgically sterile or must agree to use effective contraception
             during the period of therapy

          -  Select imaging to rule out metastasis will be done as clinically indicated

          -  Signed and date informed consent document

        Exclusion Criteria:

          -  Prior treatment for prostate cancer

          -  Major surgery or radiation therapy within 4 weeks of starting the study treatment

          -  NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy

          -  History of or known metastatic prostate cancer

          -  Any of the following within the 6 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, or pulmonary embolism.

          -  Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater

          -  QTc interval > 500 msec on baseline EKG

          -  Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal
             medical therapy).

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication

          -  Known active infection

          -  Concurrent treatment on another clinical trial. Supportive care trials or
             non-treatment trials, e.g. QOL, are allowed.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or study
             drug administration, or may interfere with the interpretation of study results, and in
             the judgment of the investigator would make the subject inappropriate for entry into
             this study.