Overview

This trial is active, not recruiting.

Conditions prostate cancer metastatic, hormone refractory prostate cancer
Treatments sipuleucel-t, abiraterone acetate
Phase phase 2
Sponsor Dendreon
Start date December 2011
End date April 2016
Trial size 69 participants
Trial identifier NCT01487863, P11-3

Summary

The purpose of this study is to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on product parameters of sipuleucel-T, and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Subjects will receive sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment will start the next day after the first infusion of sipuleucel-T and continue for 26 weeks or until disease progression, unacceptable toxicity, or death, whichever occurs first.
sipuleucel-t PROVENGE(R)
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate ZYTIGA(R)
Abiraterone acetate (1000 mg po QD) is administered in combination with prednisone (5 mg po BD) for a total of 26 weeks.
(Experimental)
Subjects will receive sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone will start 6 weeks after the last infusion of sipuleucel-T and continue for 26 weeks or until disease progression, unacceptable toxicity, or death, whichever occurs first.
sipuleucel-t PROVENGE(R)
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
abiraterone acetate ZYTIGA(R)
Abiraterone acetate (1000 mg po QD) is administered in combination with prednisone (5 mg po BD) for a total of 26 weeks.

Primary Outcomes

Measure
Evaluate cumulative sipuleucel-T CD54 upregulation
time frame: Over the course of sipuleucel-T therapy (approximately 1 month)

Secondary Outcomes

Measure
Evaluate sipuleucel-T product parameters
time frame: Over the course of sipuleucel-T therapy (approximately 1 month)
Evaluate the peripheral immune response to sipuleucel-T
time frame: From baseline through 26 weeks
Evaluate safety of sipuleucel-T therapy with concurrent or sequential administration of abiraterone acetate plus prednisone
time frame: From registration to 30 days following the last study treatment

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria

  • historically documented prostate cancer confirmed by a pathology report from prostate biopsy or radical prostatectomy specimen
  • metastatic status as evidenced by imaging obtained </= 56 days prior to registration demonstrating bone metastasis or lymph node metastasis
  • castrate resistant prostate cancer: castrate levels of testosterone (</= 50 ng/dL; evidence of disease progression concomitant with surgical or medical castration
  • serum PSA >/= 2.0 ng/mL
  • castrate levels of testosterone (</= 50 ng/dL) achieved via medical or surgical castration
  • baseline ECOG performance status of </= 1
  • systolic blood pressure (BP) </= 140 mm HG and diastolic BP </= 90 mm Hg at screening
  • adequate baseline hematologic, renal, and liver functions
  • must live in a permanent residence within a comfortable driving distance (roundtrip within one day) of the clinical trial site

Exclusion Criteria

  • the presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites
  • New York Heart Association Class III or IV heart failure
  • any medical condition that may be compromised by increases in blood pressure, hypokalemia, or fluid retention
  • Child-Pugh Class B or C hepatic insufficiency
  • spinal cord compression, imminent long bone fracture, or any other condition likely to require radiation therapy and/or steroids for pain control
  • known adrenalcortical insufficiency
  • any medical contraindications to receiving prednisone
  • prior treatment with sipuleucel-T
  • previous treatment with abiraterone acetate (Zytiga(R)) or ipilimumab (Yervoy(TM))
  • a requirement for systemic immunosuppressive therapy for any reason. Use of inhaled, intra-nasal, intra-articular, and topical steroids is allowed.
  • treatment with any investigational vaccine or immunotherapy
  • a history of stage III 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 I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.
  • myocardial infarction or ventricular or atrial arrhythmia within 6 months prior to registration
  • ongoing anti-androgen withdrawal response.
  • systemic steroid use within ≤ 60 days of registration
  • treatment with denosumab (Xgeva(R) or Prolia (R)) within ≤ 3 months prior to registration
  • positive test for HIV or HTLV infections. Subjects with a positive test for hepatitis B or hepatitis C are allowed provided they meet the LFT criteria and have no signs of acute infection or active disease.
  • treatment with any of the following medications or interventions within 28 days prior to registration: external beam radiation or major surgery requiring general anesthetic; saw palmetto; megestrol acetate (Megace(R)), diethylstilbestrol, and cyproterone; 5-alpha-reductase inhibitors (e.g. finasteride [Proscar(R)], dutasteride [Avodart(R)]); steroidal anti-androgen therapy; any other systemic therapy for prostate cancer, except for medical castration; treatment with any other investigational product for prostate cancer; substrates of CYP2D6 (e.g. including but not limited to thioridazine); inhibitors of CYP3A4 (e.g. including but not limited to ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, and voriconazole); inducers of CYP3A4 (e.g. including but not limited to phenytoin, carbamazepine, rifampin, rifapentine, and phenobarbital)
  • a requirement for treatment with opioid analgesics within 21 days prior to registration
  • an active infection or infection requiring parenteral antibiotic therapy or causing fever within 7 days of registration
  • any medical intervention, or other condition, or any other circumstance that, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives

Additional Information

Official title A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Dendreon.