Docetaxel Followed by Provenge in Metastatic Prostate Cancer

Exclusion Criteria

• •Patient has "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy \>5 years previously and have no known evidence of residual or recurrent disease.
• •Current symptomatic cord compression requiring surgery or radiation therapy
• •Prior chemotherapy for prostate cancer
• •Patient is using supplements or complementary medicines/botanicals. Patients should review the label with their doctor prior to enrolment. The following exceptions are permitted at screening and during the course of the study.
• •* Conventional multivitamin supplements
• •* Selenium
• •* Lycopene
• •* Soy supplements
• •* Vitamin E
• •* Fish oil supplements
• •* Vitamin D
• •* Glucosamine supplements
• •* Age-related eye disease vitamins
• •* Ginkgo biloba
• •Patient co-morbidities:
• •* HIV positive
• •* Acute hepatitis B (HBV) or active hepatitis C (HCV)
• •* Clinical and laboratory evidence of active bacterial, viral, or fungal infection requiring systemic treatment
• •* Clinically significant cardiovascular disease including
• •1. Symptomatic congestive heart failure
• •2. Unstable angina pectoris
• •3. Serious cardiac arrhythmia requiring medication
• •4. Uncontrolled hypertension \>150/100mm Hg (if controlled with medication this is not an exclusion).
• •5. Hypotension
• •6. Myocardial infarct or ventricular arrhythmia or stroke within a 6-month period prior to inclusion, ejection fraction (EF) \<40%, or serious cardiac conduction system disorders
• •7. Patient is exhibiting evidence of symptomatic congestive heart failure, pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina, myocardial infarction or active ischemia if a pacemaker is not present on electrocardiogram (ECG). An ECG must be performed at screening unless the subject has measurable disease in which case an ECG taken prior to screening but within 28 days of start of treatment will be accepted.
• •* Pleural and pericardial effusion of any CTCAE grade
• •* Rheumatoid disease (asymptomatic subjects with controlled and rarely flaring rheumatoid arthritis are also excluded)
• •* Peripheral neuropathy having a CTCAE grade ≥2
• •* History of malignant disease (with the exception of non-melanoma skin tumors) in the preceding 5 years
• •* Active autoimmune disease requiring treatment (except non-insulin-dependent diabetes mellitus)
• •* History of severe forms of primary immune deficiencies
• •* History of anaphylaxis or other serious reactions following vaccination
• •* Uncontrolled co-morbidities including psychiatric or social conditions which, in the Investigator's opinion, would prevent participation in the trial
• •Patient has had major surgery or radiation therapy completed \< 4 weeks prior to screening.
• •Patient has had prior exposure to the radiopharmaceuticals radium 223, strontium, or samarium within 8 weeks prior to screening.
• •Patient is receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational agents.
• •Patient has cerebral metastases (known from previous investigations or clinically detectable).
• •Patient has serum testosterone \>50 ng/dl.
• •Systemic corticosteroids at doses \>40 mg hydrocortisone daily or equivalent for any reason other than (a) prescribed as replacement therapy in the case of adrenal insufficiency or (b) oral dexamethasone administration used in combination with docetaxel.
• •Patient has in the opinion of the physician a serious or uncontrolled intercurrent infection or non-malignant medical illness which is uncontrolled.
• •Systemic immunosuppressive therapy for any reason.
• •Treatment with anti-androgens, inhibitors of adrenal-produced androgens (abiraterone), androgen receptor inhibitors (enzalutamide), or other hormonal tumor-focused treatment performed on the day of screening or within the previous 4 weeks, including any dose of megestrol acetate, finasteride, any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to screening. Progressive disease (as defined above) must be documented after discontinuation of the therapy.
• •Refusal to sign the informed consent.
• •Participation in a clinical trial using experimental therapy within the last 60 days.