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Key exclusion criteria:
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Intercurrent participation in another clinical trial for prostate cancer theray. Known brain metastases, spinal cord compression of vertebral metastases with risk of spinal cord compression. Progressive metastatic disease, as defined as increasing symptoms requiring change in medication within the previous 4 weeks. Treatment with chemotherapy, bisphosphonate therapy, external beam radiation therapy, surgery, systemic corticosteroids, megestrol acetate, DES, ketoconazole, 5-alpha-reductase inhibitors, calcitriol, IFN-alpha or other immunomodulatory medication, or any other systemic therapy for prostate cancer within 28 days of registration (excluding androgen deprivation therapy). Receipt of investigational vaccine within 1 year of registration. Receipt of any other investigational product within 28 days of registration. Known pathological long-bone fractures, or imminent pathological long-bone fractures. Antibiotic therapy or infection within 1 week prior to registration, including unexplained fever. No vaccinations against infectious disease, including influenza vaccine in the three months prior to and during the trial. Intercurrent medical, surgical or psychiatric condition, which, in the opinion of the medical monitor, may interfere with the conduct and safety of the trial. Positivity for HIV I/II, HTLV I/II, Hepatitis B or C or Syphilis. |
