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.
Media Articles Related to Provenge (Sipuleucel-T)
No added benefit found for sipuleucel-T in prostate cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2015.01.12]
Sipuleucel-T (trade name Provenge) has been approved since September 2014 for men with metastatic prostate cancer who have few or no symptoms and do not yet require chemotherapy.
OncoBriefs: PDE5 Use and Prostate Cancer, H&N, Cervical Ca (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.01.24]
(MedPage Today) -- Erectile dysfunction drugs linked to higher risk of biochemical recurrence after prostatectomy.
In women with Alzheimer's disease, prostate cancer drug slows memory loss
Source: Prostate / Prostate Cancer News From Medical News Today [2015.01.23]
Women with Alzheimer's disease showed stable cognition for a year when a drug that is more commonly used to treat advanced prostate cancer was added to their drug regimen, according to a new study...
Overcoming treatment resistance in prostate cancer: Roswell Park team proposes a new strategy
Source: Genetics News From Medical News Today [2015.01.20]
Researchers have discovered what may be a promising new approach for controlling aggressive, treatment-resistant forms of prostate cancer.
Some men with advanced prostate cancer benefit from high-dose testosterone therapy
Source: Endocrinology News From Medical News Today [2015.01.12]
In a surprising paradox, the male hormone testosterone, generally thought to be a feeder of prostate cancer, has been found to suppress some advanced prostate cancers and also may reverse resistance...
Published Studies Related to Provenge (Sipuleucel-T)
Building on sipuleucel-T for immunologic treatment of castration-resistant
prostate cancer. 
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
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.
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.
Reports of Suspected Provenge (Sipuleucel-T) Side Effects
Disease Progression (31),
Dehydration (26), more >>