PROvenge Treatment and Early Cancer Treatment
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for
      patients with hormone sensitive prostate cancer. The study was conducted at over 15
      participating centers throughout the US. The purpose of the study was to determine if
      sipuleucel-T was effective for treatment of early stage, non-metastatic prostate cancer. The
      study compared the active vaccine to control to determine whether the product delayed the
      time until cancer progression.
    

Detailed description: 
      This was a prospective, double blind, controlled, randomized trial of immunotherapy with
      prostatic acid phosphatase (PAP)-loaded autologous antigen presenting cells (APCs), in
      subjects with non metastatic prostate cancer. Subjects that qualified for this study were men
      who had previously undergone a prostatectomy and whose only sign of disease recurrence was a
      rise in serum prostate specific antigen (PSA).

      The primary objectives were to compare the time to biochemical failure (BF, PSA greater than
      or equal to 3 ng/mL) between sipuleucel-T (treatment group) and control, and to study the
      safety of sipuleucel-T.

      Following short-term open-label treatment with a luteinizing hormone-releasing
      hormone-analogue (LHRH-a), Subjects completed a checklist designed to compare androgen
      suppression-related side effects during periods with and without androgen suppression.

      Subjects who achieved a PSA of < 1 ng/ml were randomized to blinded treatment assignments of
      either sipuleucel-T or control in a 2:1 ratio. Following randomization, subjects underwent 3
      leukapheresis procedures on alternate weeks (Weeks 0, 2, and 4). Approximately three days
      following each leukapheresis procedure, subjects received an infusion of either sipuleucel-T
      or control.

      At the time BF was confirmed, subjects were eligible for a booster infusion. The booster
      process consisted of 1 leukapheresis procedure followed by 1 infusion of sipuleucel-T. The
      booster process, in effect under protocol amendment 5, differed from the previous booster
      process that consisted of 1 infusion of the same treatment assigned at randomization
      (sipuleucel-T or control).

      Subjects continued to be observed until DF was confirmed by bone scan or computed tomography
      (CT) scan, or other imaging modalities as clinically indicated. After confirmed DF, subjects
      were followed by telephone every 6 months for safety and survival, treatment-related AEs, any
      CVEs, or new therapies for prostate cancer.
    

Intervention name(s): Control; Sipuleucel-T
Intervention type(s): Other; Biological
Intervention description(s): Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen.; Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Other intervention name(s): Provenge®; APC8015
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cancer; prostate cancer; prostatectomy; PSA; sipuleucel-T; PROVENGE; APC8015; non-metastatic; nonmetastatic; androgen-sensitive; androgen sensitive; biochemical recurrence; biochemically recurrent; immune therapy; immunotherapy; vaccine; dendritic cells; antigen-presenting cells; antigen presenting cells; cancer vaccine; therapeutic vaccine; therapeutic cancer vaccine; biologic; booster