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Provenge (Sipuleucel-T) - Summary

 
 



PROVENGE SUMMARY

PROVENGE consists of autologous peripheral blood mononuclear cells, including antigen presenting cells (APCs), that have been 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 patient's peripheral blood mononuclear cells are obtained via a standard leukapheresis procedure approximately 3 days prior to the infusion date. Due to the autologous nature of PROVENGE, it is important that the patient and physician adhere to the personalized leukapheresis and infusion schedules. The active components of PROVENGE are autologous APCs and PAP-GM-CSF. During culture, the recombinant antigen can bind to and be processed by APCs into smaller protein fragments. The recombinant antigen is designed to target APCs, and may help direct the immune response to PAP. Minimal residual levels of the intact PAP-GM-CSF are detectable in the final PROVENGE product.

PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
See all Provenge indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Provenge (Sipuleucel-T)

African-American men at greater risk of prostate cancer, study finds
Source: Cancer / Oncology News From Medical News Today [2015.04.17]
Compared with non-Hispanic white men, obesity presented a higher prostate cancer risk and may be 'uniquely harmful' to African-American men, a new study finds.

Obesity Linked to Greater Risk of Prostate Cancer in Blacks, Study Says
Source: MedicineNet Obesity (Weight Loss) Specialty [2015.04.17]
Title: Obesity Linked to Greater Risk of Prostate Cancer in Blacks, Study Says
Category: Health News
Created: 4/16/2015 12:00:00 AM
Last Editorial Review: 4/17/2015 12:00:00 AM

Walking Boosts Outcomes for Prostate Cancer Survivors
Source: MedicineNet Prostate Cancer Specialty [2015.04.17]
Title: Walking Boosts Outcomes for Prostate Cancer Survivors
Category: Health News
Created: 4/16/2015 12:00:00 AM
Last Editorial Review: 4/17/2015 12:00:00 AM

Does Obesity Explain High Prostate Cancer Risk in Black Men?
Source: Medscape Today Headlines [2015.04.16]
Black men who are obese are at increased risk for prostate cancer; as body mass index increases, this risk nearly quadruples.
Medscape Medical News

U-M researchers find protein that may signal more aggressive prostate cancers
Source: Prostate / Prostate Cancer News From Medical News Today [2015.04.15]
University of Michigan researchers have discovered a biomarker that may be a potentially important breakthrough in diagnosing and treating prostate cancer.

more news >>

Published Studies Related to Provenge (Sipuleucel-T)

Building on sipuleucel-T for immunologic treatment of castration-resistant prostate cancer. [2013]
phosphatase/granulocyte-macrophage colony-stimulating factor antigen... CONCLUSIONS: There is potential to build on sipuleucel-T to further advance

Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer. [2013]
responses to overall survival (OS)... CONCLUSION: Sipuleucel-T broadly engages the immune system by activating APCs ex

Cancer immunotherapy: sipuleucel-T and beyond. [2011.08]
In April 2010, sipuleucel-T became the first anticancer vaccine approved by the United States Food and Drug Administration. Different from the traditional chemotherapy agents that produce widespread cytotoxicity to kill tumor cells, anticancer vaccines and immunotherapies focus on empowering the immune system to overcome the tumor.

Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. [2011.07.01]
CONCLUSIONS: No significant difference in time to BF could be shown. The finding of increased PSADT in the sipuleucel-T arm is consistent with its biologic activity in ADPC. Long-term follow-up will be necessary to determine if clinically important events, such as distant failure, are affected by therapy. Treatment was generally well tolerated.

Sipuleucel-T: in metastatic castration-resistant prostate cancer. [2011.01.01]
Sipuleucel-T is an autologous active cellular immunotherapy used in the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC)... infusion-related events, such as chills and fever) generally occurred within the first day after administration of sipuleucel-T and resolved within 2 days.

more studies >>

Clinical Trials Related to Provenge (Sipuleucel-T)

Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer [Recruiting]
The main purpose of this study is to determine whether ADT started before or after sipuleucel-T leads to a better immune system response. This study will also evaluate the safety of sipuleucel-T treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.

Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402) [Recruiting]
This study is being conducted to examine the immune response generated by sipuleucel-T in subjects previously treated with sipuleucel-T in the androgen dependent setting. The study will also assess the safety of receiving up to 3 additional infusions of sipuleucel-T. This is an open-label, uncontrolled, multicenter study, conducted in up to 14 clinical trial sites. The anticipated duration of the study is approximately 6 years.

Concurrent Versus Sequential Treatment With Sipuleucel-T and Abiraterone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC) [Recruiting]
The purpose of this study is to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on product parameters of sipuleucel-T, and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.

Sipuleucel-T Manufacturing Demonstration Study [Recruiting]
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer [Recruiting]
This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

more trials >>

Reports of Suspected Provenge (Sipuleucel-T) Side Effects

Asthenia (40)Chills (37)Fall (33)Anaemia (32)Disease Progression (31)Fatigue (31)Malaise (30)Hypotension (28)Nausea (26)Dehydration (26)more >>


Page last updated: 2015-04-17

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