Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Sipuleucel-T; APC-Placebo
Intervention description: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.; Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 512.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; prostate; AIPC; androgen-independent; androgen independent; hormone insensitive; hormone-insensitive; PSA; prostatic adenocarcinoma; hormone-refractory; hormone refractory; HRPC; LHRH; immune therapy; immunotherapy; vaccine; dendritic cells; antigen-presenting cells; antigen presenting cells; cancer vaccine; therapeutic vaccine; therapeutic cancer vaccine; recombinant; biological; biopharmaceutical; biotechnology; biotech

Summary:

      Provenge is an investigational product designed to activate a man's own antigen presenting
      cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an
      immune response against them.

      Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level.
      One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase
      3 study.

      If you decide to participate and are eligible, you will be enrolled in the study and randomly
      assigned to receive either active product or placebo. There are two chances in three that you
      will receive Provenge. After receiving treatment, you will be monitored at regular intervals
      until the study endpoints are met. At the end of the trial, men who received placebo will
      have the opportunity to be treated with active product in another study.
    

Eligibility criteria:

        To qualify for this trial, you must have ALL of the following:

          -  Histologically documented adenocarcinoma of the prostate

          -  Cancer that has progressed while on adequate hormone therapy. This state of the
             disease is androgen independent prostate cancer (AIPC).

          -  Cancer that has spread outside the prostate (metastatic) to lymph nodes or bone.
             Please note that if your cancer has spread to organs (e.g., liver, lung, brain), you
             are not eligible for the study.

          -  The absence of or minimal current cancer-related pain

        Please note that there are additional eligibility criteria. The study center will determine
        if you meet all of the criteria.

        Study personnel will explain the trial in detail and answer any questions you may have if
        you do qualify for the study. You can then decide whether or not you wish to participate.
        If you do not qualify for the trial, study personnel will explain the reasons.