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Provenge (Sipuleucel-T) - 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 >>


Media Articles Related to Provenge (Sipuleucel-T)

First Head-to-Head of Chemo for Prostate Cancer
Source: Medscape Hematology-Oncology Headlines [2017.08.09]
The first head-to-head comparison of two chemotherapies for prostate cancer finds similar survival gains but different toxicity profiles.
Medscape Medical News

Bone Up on Prostate Cancer Treated With ADT
Source: Medscape Hematology-Oncology Headlines [2017.08.08]
Androgen deprivation therapy for prostate cancer causes significant bone loss. A new study reviews the effectiveness of bone health drugs.
Medscape Medical News

4K Test May Help Avert Unnecessary Prostate Cancer Treatment
Source: Medscape Pathology & Lab Medicine Headlines [2017.08.08]
New data make a very strong case for incorporating the 4K test into standard management of men advised to undergo prostate biopsy because of PSA test results, according to Dr Gerald Chodak.
Medscape Urology

Osteoporosis medications improve bone health in men with prostate cancer receiving androgen deprivation therapy
Source: Bones / Orthopedics News From Medical News Today [2017.08.08]
Both biophosphonates and denosumab improve bone mineral density (BMD) in men with nonmetastatic prostate cancer who are receiving androgen deprivation therapy (ADT).

Immediate vs Delayed ADT in Prostate Cancer: QoL Data
Source: Medscape Hematology-Oncology Headlines [2017.08.07]
Men with biochemical relapse had mostly similar quality of life, regardless of whether androgen deprivation therapy was immediate or delayed.
Medscape Medical News

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)

Ph 2 Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC [Not yet recruiting]
This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer. It has been suggested that the immune response may be strengthened by radiation therapy. Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune response and anti-tumor effect against prostate cancer.

Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer [Completed]
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 Manufacturing Demonstration Study [Active, not 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, CT-011, and Cyclophosphamide for Advanced Prostate Cancer [Recruiting]

- Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a

person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment. Objectives:

- To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate

cancer. Eligibility:

- Men at least 18 years of age who have advanced prostate cancer.


- Participants will be screened with a medical history, physical exam, blood and urine

tests, and imaging studies.

- This study has two parts, with different participants in each part. All participants

will be monitored with frequent blood tests and imaging studies.

- Part I:

- Participants will provide cells for the Sipuleucel-T treatment three times. The first

time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy.

- Participants will have one dose of cyclophosphamide the day before the first dose of


- Participants will have Sipuleucel-T about 3 days after each cell donation.

- Part II:

- Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or

given with both cyclophosphamide and CT-011.

- Participants will provide cells for the Sipuleucel-T treatment three times, as in Part


- Participants will have Sipuleucel-T about 3 days after each cell donation, and will

receive treatment with the other drugs as directed by the study doctors.

Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402) [Active, not 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.

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: 2017-08-09

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