Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy

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.