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Why PROVENGE Immunotherapy?

Why PROVENGE Immunotherapy?

PROVENGE is the first personalized, FDA-approved, immunotherapy that is clinically proven to extend life for certain men with metastatic castration-resistant prostate cancer (mCRPC).

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

PROVENGE works differently from other advanced prostate cancer treatment options by using the patient’s own immune cells, cultured with a recombinant 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. With a unique mechanism of action, PROVENGE provides a robust immune response with a manageable safety profile.

In IMPACT, PROVENGE Significantly Extended Overall Survival In Certain Patients With mCRPC2

IMPACT, the pivotal clinical trial, showed that men who received PROVENGE lived 4.1 months longer than men in the control group. However, a post hoc analysis of the IMPACT data suggested that men who started PROVENGE with lower PSA levels lived even longer.3

This post hoc analysis was not powered for statistical significance, and the population within the subgroups was not randomized. Therefore, the findings are limited by their exploratory nature.

The PROCEED registry was an observational study that evaluated the safety and survival of nearly 2,000 men who received PROVENGE. The patients were followed between 2011 and 2017. This registry evaluated the safety and survival profile of PROVENGE received by patients in a real-world setting in which there was no control group. The study was conducted to quantify the risk of cerebrovascular events and secondarily survival. Patients could have received subsequent anti-cancer interventions, per the local investigator’s standard of care.

In a post hoc analysis of the PROCEED Registry, men with mCRPC with a baseline prostate-specific antigen (PSA) level ≤5.27 ng/mL who received PROVENGE had a median overall survival of nearly 4 years.

This subgroup analysis of the PROCEED registry was exploratory and results need careful interpretation.

Manageable Safety Profile

The most common side effects of PROVENGE are generally mild to moderate, well tolerated and include chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Some patients have experienced serious adverse events while taking PROVENGE. See Important Safety Information for more details.

Immune Responses Observed

A sustained immune response of up to 26 weeks (the last time point measured) was observed in men who received PROVENGE in IMPACT.4

An example of the immune response measured was antigen cascade, which represents a sequential immune response against antigens.

(No conclusions could be made regarding the clinical significance of the observed immune response.)

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A Sustained Immune Response Was Observed Up to 26 Weeks4

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Immunotherapy Induced Antigen Spread

One mechanism of action of immunotherapy is to induce an immune response against antigen-bearing tumor cells; the resultant cell death releases secondary (non targeted) tumor antigens. Secondary antigens prime subsequent immune responses (antigen spread). Immunotherapy-induced antigen spread has been shown in clinical studies. For example, in metastatic castration-resistant prostate cancer patients, sipuleucel-T induced immune responses to the immunizing antigen (PA2024) and/or the target antigen (prostatic acid phosphatase).4 Thereafter, increased antibody responses to numerous secondary proteins were observed, several of which are expressed in prostate cancer with functional relevance in cancer.5

For more discussion on immune response, talk to the Medical Affairs team.

senior man talking to young physician

The Importance Of Patient Identification

Early identification of men with mCRPC who are indicated for PROVENGE is key to achieving optimal clinical benefit. More than 32% of men across multiple trials who were assumed to be non metastatic were found to have metastatic disease upon regular imaging.

doctor smiling at clipboard with patient

Helping Patients Navigate Their Treatment Options

For men with prostate cancer, understanding the available treatment options can be challenging.

For example, in IMPACT, PROVENGE was shown to provide a survival advantage in certain men regardless of their baseline PSA level. An exploratory analysis suggests that men who start PROVENGE when their PSA level is lower live longer.3 Regular imaging to diagnose metastatic progression as early as possible is important in optimizing treatment options.

Your patient may find it helpful to hear from others who have chosen PROVENGE to improve their chances of living longer.

Click here to find out more about educational patient programs.

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As the first personalized immunotherapy for prostate cancer, PROVENGE is unlike other treatments such as hormone therapy, chemotherapy, or surgery. Find answers to frequently asked questions about PROVENGE.

1 Higano CS, Armstrong AJ, Sartor AO, et al. Real-world outcomes of sipuleucel-T treatment in PROCEED, a prospective registry of men with metastatic castration-resistant prostate cancer. Cancer. 2019;125(23):4172-4180. DOI: 10.1002/cncr.32445.
2 Kantoff PW, Higano CS, Shore ND, et al. IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363(5): 411-422. DOI: 10.1056/NEJMoa1001294.
3 Schellhammer PF, Chodak G, Whitmore JB, et al. Lower baseline prostate-specific antigen is associated with a greater overall survival benefit from sipuleucel-T in the Immunotherapy for Prostate Adenocarcinoma Treatment (IMPACT) trial. Urology. 2013;81(6):1297-1302. DOI: 10.1016/j.urology.2013.01.061.
4 Sheikh NA, Petrylak D, Kantoff PW, etc. Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer. Cancer Immunology Immunotherapy. 2013;62: 137-147. DOI: 10.1007/s00262-012-1317-2.
5 Gulley JL. Therapeutic vaccines: the ultimate personalized therapy? Hum Vaccin Immunother. 2013;9(1):219-221.D.O.I.: 10.4161/hv.22106.

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.


Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Full Prescribing Information.

To report an adverse event, please email our Pharmacovigilance department at, or fax adverse event details to 833-464-0123. Please provide details pertaining to the adverse event and provide contact information so that our Pharmacovigilance team may contact you with any questions.
To report a product complaint, email our Quality department at Please provide details pertaining to the quality issue and provide contact information so that our Quality team may contact you with any questions.