Provenge active components are autologous antigen-presenting cells (APCs) and the protein called PAP-GM-CSF.
APCs are activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM‑CSF), an immune cell activator.
The cellular composition of Provenge will vary, depending on the cells obtained from the individual patient during leukapheresis. In addition to the APCs, the product also contains T cells, B cells, natural killer (NK) cells, and other cells.
Provenge is specifically indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.
Provenge is administered intravenously in a three-dose schedule at approximately two-week intervals. Each dose is preceded by the leukapheresis procedure approximately three days prior to the scheduled treatment and is administered only to the patient from whom the cells were obtained.
Clinical Trial NCT00065442: Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy (Completed)
- The trial is being conducted at multiple study centers throughout the United States.
- The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria.
- Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center.
Clinical Trials NCT00779402: PROvenge Treatment and Early Cancer Treatment (PROTECT) (Completed)
- 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.
Clinical Trial NCT01306890: A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (PROCEED) (Completed)
- Subjects will receive the product as described in the sipuleucel-T approved label.
- The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice.
- Investigators will be asked to record information that becomes available in the normal course of clinical management.