Media Articles Related to Provenge (Sipuleucel-T)
Among Patients Carrying BRCA Mutations, PARP Inhibitor Shows Activity In Pancreatic, Prostate Cancers
Source: Health News from Medical News Today [2013.05.18]
In the largest clinical trial to date to examine the efficacy of PARP inhibitor therapy in BRCA 1/2 carriers with diseases other than breast and ovarian cancer, the oral drug olaparib was found to be effective against advanced pancreatic and prostate cancers. Results of the study, led by researchers from the Perelman School of Medicine at the University of Pennsylvania and Sheba Medical Center in Tel Hashomer, Israel, will be presented during the American Society of Clinical Oncology's annual meeting in Chicago in early June (Abstract #11024)...
Advanced Prostate Cancer Drug Xofigo Approved By FDA
Source: Health News from Medical News Today [2013.05.17]
Xofigo (radium Ra 223 dichloride) has been approved by the US FDA for symptomatic late-stage (metastatic) castration-resistant prostate cancer that has reached bones but not other organs, i.e. with no known visceral metastatic disease. The Food and Drug Administration (FDA) approved Xifogo under the priority review program, three months ahead of schedule. According to an online FDA communiquÃÂ© published this week, Xofigo is aimed at male patients whose prostate cancer metastasized despite receiving medical or surgical interventions to reduce testosterone levels...
Xofigo Approved for Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2013.05.17]
Title: Xofigo Approved for Prostate Cancer
Category: Health News
Created: 5/16/2013 4:36:00 PM
Last Editorial Review: 5/17/2013 12:00:00 AM
Androgen Deprivation Therapy For Prostate Cancer Can Cause Osteoporosis
Source: Bones / Orthopedics News From Medical News Today [2013.05.16]
Androgen deprivation therapy is a common and effective treatment for advanced prostate cancer. However, among other side-effects, it can cause significant bone thinning in men on long-term treatment...
FDA Approves New Drug to Fight Advanced Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2013.05.16]
Title: FDA Approves New Drug to Fight Advanced Prostate Cancer
Category: Health News
Created: 5/15/2013 12:36:00 PM
Last Editorial Review: 5/16/2013 12:00:00 AM
Published Studies Related to Provenge (Sipuleucel-T)
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.
Cancer immunotherapy: sipuleucel-T and beyond. 
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.
Integrated safety data from 4 randomized, double-blind, controlled trials of
autologous cellular immunotherapy with sipuleucel-T in patients with prostate
randomized, controlled studies in patients with prostate cancer... CONCLUSIONS: Sipuleucel-T therapy in patients with prostate cancer has a side
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.
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.
- To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate
- 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.
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.
Reports of Suspected Provenge (Sipuleucel-T) Side Effects
Disease Progression (31),
Dehydration (26), more >>