Prostate Cancer Clinical Trials

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

• Males 18 years or older
• Pathologically confirmed adenocarcinoma of the prostate
• PSA > 5 ng/mL or radiographically measurable disease
• Evidence of metastatic disease on bone scan or other imaging
• Progressive disease after at least 1 hormonal treatment
• Concurrent use of an agent for testosterone suppression is required if the patient has not been surgically castrated
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Recovered to less than or equal to Grade 1 toxicity (CTCAE), to patient's baseline status (except alopecia) or deemed irreversible from the effects of prior cancer therapy and must have evidence of progressive or persistent disease
• Adequate bone marrow, liver and renal function
• Any use of opiates must be stable for at least 2 weeks prior to study entry
• Patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
• Voluntary written consent
• Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
• Suitable venous access for blood sampling

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

• Prior treatment with antineoplastic chemotherapy or radioisotopes for metastatic prostate cancer
• Prior or current investigational therapies within 4 weeks before the first dose of MLN8237
• Radiotherapy or antiandrogen therapy for prostate cancer within 4 weeks prior to enrollment
• Use of products known to affect PSA levels within 4 weeks of enrollment
• Radiotherapy to greater than 25% of bone marrow
• Localized radiation within 4 weeks of enrollment
• Compromised bone marrow including patients with a superscan result on a bone scan
• Major surgery within 4 weeks of study enrollment
• Uncontrolled high blood pressure
• Patients receiving chronic steroid therapy other than the following: low dose steroid for the control of nausea and vomiting, topical steroid, inhaled steroid or use of dexamethasone
• Known severe hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
• Comorbid condition or unresolved toxicity that would preclude administration of docetaxel and prednisone
• Medical contraindication to any of the docetaxel pre-medications
• Prior history of Grade 2 or greater neurotoxicity or any toxicity that has not resolved to Grade 1 or below
• Symptomatic brain or other CNS metastasis
• Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
• Patients requiring full systemic anticoagulation
• Prior allogeneic bone marrow or other organ transplant
• Active infection requiring systemic therapy within 14 days preceding first dose, or other serious infection
• History of hemorrhagic or thrombotic cerebrovascular event in the past 12 months
• Serious medical or psychiatric illness that could interfere with protocol completion
• Inability to swallow oral medication
• Uncontrolled pain at baseline, impending complication from bone metastasis and/or presence of urinary obstruction