A Randomized, Open-Label, Phase II Study of Sipuleucel-T with Concurrent vs Sequential Administration of Enzalutamide in Men with Metastatic Castrate Resistant Prostate Cancer
Trial Purpose and Description
This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.
- Written informed consent provided prior to the initiation of study procedures.
- Age &ge 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 (&le 50 ng/dL) achieved via medical or surgical castration.
- Serum PSA &ge 2.0 ng/mL.
- Screening ECOG performance status &le 1
- Adequate screening hematologic, renal, and liver function as evidenced by laboratory test results obtained &le 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.
- 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 &ge 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 &ge 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 &le 2 years prior to registration.
- Use of concomitant medications that may lower the seizure threshold or the use of antiseizure medications &le 1 year prior to registration.
- Received GM-CSF or G-CSF &le 90 days prior to registration.
- Ongoing non-steroidal antiandrogen withdrawal response.
Any of the following medications or interventions &le 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.
- 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 &le 21 days prior to registration.
- An active infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5° F or 38.1° C) &le 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.
- Dendreon Corporation
- Last Updated:
- Study HIC#: