Phase II Sunitinib Prog Met AIPC

Inclusion Criteria

• A patient will be eligible for inclusion in this study if he meets all of the following criteria:
• Histologically confirmed, adenocarcinoma of the prostate
• Stage IV(metastatic) disease, documented on CT, MRI, or X-ray
• Progressive disease (PSA or clinical): PSA progression defined as baseline increase followed by any serial increase after 2 weeks; clinical progression by symptomatic or radiologic criteria.
• An elevated PSA level of for patients progressing by PSA criteria is required
• Currently on androgen ablation hormone therapy (an LHRH agonist or orchiectomy) with testosterone level 50% of the bone marrow
• Is receiving concurrent immunotherapy
• Has a history of hypersensitivity to any of the components of Sutent: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients. The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The caramel gelatin capsule shells also contain yellow iron oxide and black iron oxide. The printing ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide.
• Has had significant bleeding in previous 4 weeks
• Has had any of the following within the prior 6 months: severe/unstable angina, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism
• Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started within the prior 8 weeks will not be allowed since this may affect other study endpoints and render their interpretation difficult
• Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole, corticosteroids, or an investigational agent within 4 weeks prior to registration, (6 weeks for radiation therapy, nitrosureas or Mitomycin C)
• Has uncontrolled arrhythmia or hypertension
• Has evidence of uncontrolled CNS involvement (previous radiation and off steroids is acceptable)
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
• Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin), which could affect the diagnosis or assessment of any of the study drugs
• Is unable to comply with requirements of study