FDA: Prostate Cancer Vaccine (Provenge) Frequently Asked Questions and Answers

What is Provenge? How does it work?

Provenge

Provenge (sipuleucel-T), which some translate as “Provenge,” is an autologous cellular immunotherapy that works by stimulating the patient’s own immune system to fight cancer.

Provenge is produced in several steps:

  • First, white blood cells are collected from the patient’s blood through a machine, a process known as single-collection leukocyte harvesting.
  • Subsequently, these immune cells are stimulated, directed by certain proteins, to attack prostate cancer cells.
  • Finally, some of these activated immune cells are then transfused back to the patient to attack the prostate cancer cells.

Provenge is given by intravenous injection, 3 injections in total, each 2 weeks apart.

Three days before the scheduled injection date, the provider will isolate immune cells from the patient by single-collection of leukocytes, and these immune cells will be isolated for the patient’s use only.

What are the ingredients in Provenge?

The main active ingredients of Provenge are:

  • Autologous antigen presenting cells (APCs), which we can call “little A”;
  • Recombinant human protein PAP-GM-CSF, which we can call “little P”.

“Little P” (PAP-GM-CSF ) is a combination of prostatic acid phosphatase (PAP, a prostate cancer tissue-expressed antigen) and granulocyte-macrophage colony-stimulating factor (GRM-CSF). macrophage colony-stimulating factor (GM-CSF, an immune cell activator).

Little A”is activated during culture with “Little P”.

The Provenge obtained by single harvesting of leukocytes varies from patient to patient and includes T cells, B cells, natural killer cells (NK cells), and other types of immune cells in addition to antigen-presenting cells (“Little A”).

Each dose of Provenge is dissolved in 250 mL of lactated Ringer’s injection and is used only in the corresponding patient.

There are no preservatives or additives in Provenge.

What kind of cancer does Provenge treat?

Results from clinical trials show that Provenge is indicated for patients with asymptomatic or mildly symptomatic metastatic desmoid-resistant prostate cancer.

Can patients be treated with Provenge along with other treatments?

There are no studies on whether Provenge therapy can be combined with chemotherapy or immunosuppressants (such as corticosteroids) to treat prostate cancer.

Provenge therapy works by stimulating the systemic immune system, and the concomitant use of immunosuppressants may alter its effectiveness and safety. Therefore, patients should be carefully evaluated before treatment with Provenge and whether immunosuppressive drugs need to be reduced or stopped.

Is there an age limit for Provenge?

Provenge is not age-restricted, and prostate cancer is more common in older men. And in controlled clinical trials, most men were over 65 years old.

What are the current treatment options for patients with advanced prostate cancer?

Metastatic androgen non-dependent (depression-resistant) prostate cancer is usually incurable. The currently available treatments are aimed at relieving the patient’s suffering and prolonging survival. These treatments include intensive endocrine therapy, bisphosphonates to relieve bone metastases, chemotherapy, palliative radiotherapy, and pain management.

What adverse reactions have been reported in clinical studies of Provenge?

In a clinical study that included 601 patients, common adverse reactions in patients treated with Provenge included chills, fatigue, fever, back pain, nausea, joint pain, and headache, which ranged from mild to moderate, with severe adverse reactions primarily including acute infusion reactions and stroke.

What is the efficacy of Provenge?

In a randomized, double-blind, placebo-controlled, multicenter clinical study, investigators studied the effectiveness of Provenge in 512 patients with metastatic desmoid-resistant prostate cancer. The study showed that patients treated with Provenge had an overall survival extension of about 4 months compared with the control group.

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