a study of sipuleucel-t with administration of enzalutamide in men with metastatic castrate-resistant prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: this is a randomized, open-label study designed to assess the effects of sipuleucel-t when administered concurrently or sequentially with enzalutamide.

this is a randomized, open-label study designed to assess the effects of sipuleucel-t when administered concurrently or sequentially with enzalutamide. this study consists of 3 phases. the screening phase will begin at the completion of the informed consent process and continue through registration. the active phase will begin at registration and continue through the post-treatment visit (30 to 37 days following the last study treatment). the long term follow-up (ltfu) phase will begin after the post-treatment visit and will continue until the subject's death or until dendreon terminates the study.

Eligibility criteria:
inclusion criteria: * written informed consent provided prior to the initiation of study procedures. * age ≥ 18 years. * histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. * metastatic disease as evidenced by bone metastasis or lymph node metastasis. * castrate-resistant prostate cancer as demonstrated by one of the following: * prostate specific antigen progression. * progression of measurable disease. * progression of non-measurable disease by soft tissue disease or bone disease. * castration levels of testosterone (≤ 50 ng/dl) achieved via medical or surgical castration. * serum psa (prostate specific antigen) ≥ 2.0 ng/ml. * screening ecog (the eastern cooperative oncology group )performance status ≤ 1 * adequate screening hematologic, renal, and liver function as evidenced by laboratory test results obtained ≤ 28 days prior to registration. * negative serology test for human immunodeficiency virus 1 and 2. * resides within driving distance (round trip within 1 day) of the clinical trial site for the duration of the active phase. exclusion criteria: * the presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites. * spinal cord compression, imminent long bone fracture, or any other condition that is likely to require radiation therapy and/or steroids for pain control during the active phase. * history of stage 3 or greater cancer, excluding prostate cancer. basal or squamous cell skin cancers must have been adequately treated and the subject must be disease free at the time of registration. subjects with a history of stage 1 or 2 cancer must have been adequately treated and been disease free for ≥ 3 years at the time of registration. * history of seizures or of predisposing factors for seizures. * child-pugh class c hepatic insufficiency. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-t, gm-csf or granulocyte colony stimulating factor (g-csf). * previous treatment with sipuleucel-t or enrollment in a sipuleucel-t trial, regardless of whether the subject received sipuleucel-t or control. * previous treatment with enzalutamide. * previous treatment with abiraterone acetate. * previous treatment with ipilimumab. * previous treatment with ketoconazole other than topical use or for treatment of infections (e.g., oral thrush); most recent use must have been ≥ 7 days prior to registration. * previous treatment with any immunotherapy or investigational vaccine. * a requirement for ongoing systemic immunosuppressive therapy. use of inhaled, intranasal, intra-articular, and topical steroids is allowed. oral or iv steroids to prevent or treat iv contrast reactions are allowed. * previous treatment with chemotherapy for mcrpc, or chemotherapy for any reason ≤ 2 years prior to registration. * use of concomitant medications that may lower the seizure threshold or the use of antiseizure medications ≤ 1 year prior to registration. * received gm-csf or g-csf ≤ 90 days prior to registration. * ongoing non-steroidal antiandrogen withdrawal response. * any of the following medications or interventions ≤ 28 days prior to registration: * radiation therapy, either via external beam or brachytherapy. * any systemic steroid. use of inhaled, intra-nasal, intra-articular, and topical steroids is allowed. oral or iv steroids to prevent or treat iv contrast reactions are allowed. * any systemic therapy for prostate cancer, except for adt (androgen deprivation therapy). * any investigational product for prostate cancer. * major surgery requiring general anesthesia, with the exception of placement of central venous catheters. * inducers and inhibitors of cytochrome p450 (cyp) enzyme cyp2c8 (gemfibrozil and rifampin). * medications that are metabolized by cyp3a4, cyp2c9, or cyp2c19 that have a narrow therapeutic index. * inducers of cyp3a4 (including but not limited to phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, and phenobarbital). * a requirement for treatment with opioid analgesics for cancer-related pain ≤ 21 days prior to registration. * an active infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5˚ f or 38.1˚ c) ≤ 1 week prior to registration. * any medical intervention, any other condition, or any other circumstance which could compromise adherence with study requirements or otherwise compromise the study's objectives.