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 Phase

Phase II

Trial Purpose and Description

Trial Purpose

This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.

Participation Guidelines


Eligibility Criteria

Inclusion Criteria:

  • 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.

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 &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:
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