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4P-13-5-A Randomized, Open-Label, Phase 2 Study of Sipuleucel-T with Concurrent versus Sequential Administration of Enzalutamide in Men with Metastatic Castrate-Resistant Prostate Cancer

Description

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.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion 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 ≥ 2.0 ng/mL.
  • Screening ECOG 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.

  • 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.
  • 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

Sites

  • Arizona

    • Urological Associates of Southern Arizona, P.C., Tucson, Arizona, 85741
  • Colorado

    • The Urology Center of Colorado, Denver, Colorado, 80211
  • Washington

    • Northwest Medical Specialties, Rainier Physicians, Tacoma, Washington, 98405
    • Virginia Mason Medical Center, Virginia Mason Hospital, Seattle, Washington, 98101
  • Nebraska

    • GU Research Network, Omaha, Nebraska, 68130
  • Illinois

    • Uro Partners/ RMD Clinical Research, Melrose Park, Illinois, 60160
  • Tennessee

    • Urology Associates, PC, Nashville, Tennessee, 37209
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