Prostate Cancer Vaccine Approved By The Fda
Theres good news for patients with metastatic prostate cancer who have been eagerly awaiting a new treatment option. In April 2010, the FDA approved sipuleucel-T , a vaccine that uses the immune system to fight advanced stage disease.
Unlike a preventive vaccine, which boosts the immune system to protect people from illness, sipuleucel-T is a therapeutic vaccine. It shows the immune system what the tumor cells look like and primes immune cells to attack when they encounter lingering tumor cells.
The approval of the vaccine follows the release of data in 2009 from the phase III Immunotherapy for Prostate Adenocarcinoma Treatment study.* The study followed more than 500 men with advanced stage prostate cancer who no longer responded to hormone therapy. The participants were randomly assigned to receive the vaccine or an inactive placebo. Among those treated with sipuleucel-T, the median survival time increased by over four months and the chance of living at least three years after treatment improved by 38%.
Patients receive the drug intravenously. Its given three times over the course of a month. Common side effects reported by study participants included chills, fever, back pain, nausea, headache, and fatigue. Approximately one quarter of patients treated with the vaccine experienced severe adverse events, including infusion reactions and stroke.
Originally published September 2010 last reviewed March 31, 2011.
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Newer Treatments For Early
Researchers are looking at newer forms of treatment for early-stage prostate cancer. These new treatments could be used either as the first type of treatment or after unsuccessful radiation therapy.
One treatment, known as high-intensity focused ultrasound , destroys cancer cells by heating them with highly focused ultrasonic beams. This treatment has been used in some countries for a while, and is now available in the United States. Its safety and effectiveness are now being studied, although most doctors in the US dont consider it to be a proven first-line treatment for prostate cancer at this time.
Advances In Prostate Cancer Research
Nanoparticles are tested as a means to deliver drugs to prostate cancer cells.
NCI-funded researchers are working to advance our understanding of how to prevent, detect, and treat prostate cancer. Most men diagnosed with prostate cancer will live a long time, but challenges remain in choosing the best treatments for individuals at all stages of the disease.
This page highlights some of the latest research in prostate cancer, including clinical advances that may soon translate into improved care, NCI-supported programs that are fueling progress, and research findings from recent studies.
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A New Treatment For Advanced Prostate Cancer Improves Survival In Phase 3 Clinical Trial
- By Charlie Schmidt, Editor, Harvard Medical School Annual Report on Prostate Diseases
Radiation therapy is getting more precise, enabled by technologies that make it easier to kill tumors while sparing their surrounding tissues. Some newer therapies are even given intravenously instead of by machines, and they deliver radiation particles directly to the cancer cell itself. One of these new therapies a sort of smart bomb targeted at malignant cells is now generating promising data for men with the most aggressive prostate cancer.
In early June, investigators reported results from a phase 3 clinical trial showing that among men who received the experimental treatment, there was nearly a 40% reduction in deaths over the course of the study, compared to men who did not.
The treatment is called lutetium-177-PSMA-617, or LuPSMA, and it has two components: a compound that targets a cancer cell protein called prostate-specific membrane antigen, or PSMA, and a radioactive particle that destroys the cells. Healthy prostate cells don’t contain PSMA, or do at very low levels. And some men with prostate cancer have more of the protein than others. Doctors can detect the protein using a specialized imaging scan.
Results after 21 months showed that cancer progression was delayed for longer among the LuPSMA-treated men: 8.7 months on average versus 3.4 months among the controls. The treatment was also associated with better overall survival: 15.3 months versus 11.3 months.
Study Design And Patients
The study was an open-label, phase I/II trial. Patients previously treated with RP were identified, informed and followed at Copenhagen Prostate Cancer Center, Department of Urology, University of Copenhagen, Rigshospitalet. Vaccinations were administered at Zelo Phase I Unit, DanTrials ApS, Copenhagen, Denmark. All patients gave informed consent. Prior to study entry, patients underwent screening procedures including a full physical examination, and in case of BCR, a metastatic workup with computer tomography and bone scans. For inclusion and exclusion criteria, see . The primary endpoint of the study was the evaluation of the safety and tolerability of the vaccine. Treatment-emergent adverse events were analyzed in accordance with the common terminology criteria for adverse events , V.4.03. The secondary endpoint was the investigation of the immunological responses against the vaccine.
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Immunotherapy: Vaccines For Prostate Cancer
Immunotherapies are treatments that harness the power of the immune system to fight cancer. These treatments can either help the immune system attack the cancer directly or stimulate the immune system in a more general way.
One type of treatment vaccine called sipuleucel-T is approved for men with few or no symptoms from metastatic CRPC.
A Trial Of A Vaccine Called Prostvac For Prostate Cancer
Please note – this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new vaccine called PROSTVAC for prostate cancer that has spread.
If prostate cancer has spread outside the prostate gland, doctors often treat it with hormone therapy. This can work very well, but at some stage the cancer may start to grow again. This may not cause symptoms, but your doctor might see changes on a scan or there may be an increase in the level of PSA in your blood.
The immune system can recognise and kill cancer cells. But it is not always very good at doing this. In this trial, researchers are looking at a vaccine called PROSTVAC that can help the immune system to recognise and attack prostate cancer cells.
GM-CSF is a type of growth factor. Growth factors are proteins made in the body and some of them make the bone marrow produce blood cells. GM-CSF makes the body produce white blood cells. The researchers want to find out if giving GM-CSF alongside the vaccine can help it to work better.
The men taking part in this trial have prostate cancer that scans or blood tests show is getting worse. But their cancer is not causing symptoms or only causing very mild symptoms. The researchers will compare men in 3 groups
- PROSTVAC alongside GM-CSF
- PROSTVAC alongside a dummy drug
- PROSTVAC dummy drug alongside GM-CSF dummy drug
The aims of the trial are to
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Immunotherapy For Prostate Cancer Includes Two Fda
The prostate is a small, walnut-shaped gland that is part of the male reproductive system. The prostate is located just below the bladder, where it surrounds the top portion of the urethra . The main function of the prostate gland is to secrete fluid that nourishes and protects sperm.
As the second most common male cancer in the world, prostate cancer affects roughly 1.3 million people and kills more than 360,000 people each year, which represents about 4% of all cancer deaths worldwide. In the United States alone, there will be roughly 248,000 new cases and more than 34,000 deaths in 2021. Prostate cancer, the eighth leading cause of cancer-related deaths, will impact an estimated 1 in every 7 men in their lifetimes.
In its early stages, prostate cancer is highly treatable, with five-year survival rates close to 100%. Once prostate cancer has metastasized, however, the 5-year survival rate falls to less than 30%, highlighting a significant need for more effective treatment of advanced stage disease.
Prostate Cancer Vaccine Sipuleucel
Most vaccines prevent you from getting sick. They prime your immune system to recognize germs and defend against them. Sipuleucel-T is a different kind of vaccine. It treats cancer by teaching your immune system to find and kill cancer cells.
Sipuleucel-T can’t help everyone who has prostate cancer. It might be an option for you if:
- Your prostate cancer has spread.
- You have few or no symptoms.
- Hormone therapy for your prostate cancer hasn’t helped. That treatment uses drugs or surgery to reduce the hormones your cancer needs to grow.
Sipuleucel-T is the only approved prostate cancer vaccine. It’s tailor-made for you using your own immune cells.
To give you this treatment, first your medical team connects you to a machine that filters some of the immune cells out of your blood. You go back home. The sample of cells go to a lab. The lab staff exposes them to a protein that stimulates the cells and programs them to fight prostate cancer.
Once the cells are ready about 3 days later, you visit your doctor’s office or hospital again. They give the powered-up cells back to you in an IV. You get three doses in total, 2 weeks apart. Each dose takes about an hour.
Sipuleucel-T doesn’t stop prostate cancer cells from growing. It also doesn’t lower your level of PSA, a protein in your blood that signals prostate cancer. But it might help you live longer.
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Moving On From Sipuleucel
- 1Dendritic Cell Research, ANZAC Research Institute, Concord, NSW, Australia
- 2Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia
- 3Department of Medical Oncology, Concord Repatriation General Hospital, Concord, NSW, Australia
- 4Department of Medical Oncology, Chris O’Brien Lifehouse, Camperdown, NSW, Australia
- 5Garvan Institute of Medical Research, Darlinghurst, NSW, Australia
Why Does Recurrence Happen After Treatment
Sadly, even after an apparently successful primary treatment, cancer can still come back. Its the nature of cancer itself. As with all tumor cancers, PCa starts when normal cells mutate into malignant cells. Eventually they begin to duplicate themselves they also have the potential to biochemically form more dangerous mutations . As a tumor grows and progresses, its cells can break away and begin to spread via the blood and lymph system. This process is called metastasis. All primary treatments have the goal of removing or destroying every tumor cell so theres nothing left to spread.
In some cases, however, microscopic cells have already escaped even before the primary treatment. These cells must overcome the many hurdles they face from the bodys immune defense system, but it is difficult to detect them until they have finally begun to cluster into one or more tumors somewhere else in the body. The first sign of this is usually a rise in PSA, which is called biochemical recurrence. Recurrence is scary, because so far there is no known cure for metastatic PCa.
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Can Metastasis Be Prevented
This is where RV001 comes in! According to RhoVacs website, RV001 is a type of immunotherapy vaccine that is designed specifically for preventing or eliminating metastatic cancer cells, irrespective of cancer type. It uses the biochemistry of the metastatic cells to pre-program the immune systems killer T-cells to assassinate thema lethal hurdle that, it is hoped, no rogue cell can escape. Heres how it works:
Metastatic cancer cells over-express a protein called RhoC. It is this protein that lends to the metastatic potential cancer cells their ability to migrate and infiltrate other tissue. RhoVacs drug candidate, RV001, is an immuno-oncologic drug that is presented to the immune system as an antigen, stimulating T-cells to identify and destroy cells that carry this protein, i.e. metastatic or metastatic potential cells.
In other words, the immune system is programmed to seek and destroy cancer cells that are identified by the protein they carry.
Provenge Therapy Advanced Prostate Cancer Treatment
Urologists at UCLA Urology are offering Provenge, a treatment option for advanced prostate cancer. UCLA Urologists were collaborators on clinical trials that helped lead to the U.S. Food and Drug Administration approval of Provenge in 2010, and have been treating patients with Provenge at the Clark Urology Center since 2003.
Provenge for Prostate Cancer
What is Provenge? Provenge is the first therapeutic cancer vaccine to receive approval from the U.S. FDA. For patients with advanced prostate cancer, Provenge is an immunotherapy treatment that utilizes the power of the patients own immune system to identify and target prostate cancer cells. Provenge is available for patients being treated at UCLA Urology as part of our standard of care regimen.
What is Immunotherapy?
Immunologic agents are used to stimulate a patients own immune system to respond against the cancer.
Urologists and researchers at UCLA Urology have been pioneers in using immunotherapy in treating urologic cancers since as early as 1976.
Who is a Candidate for Provenge?
Provenge is approved for men with advanced, metastatic prostate cancer with few or no cancer-related symptoms and that is resistant to hormone therapy.
How Does Provenge Work?
This process activates the patient’s immune cells to help the immune system better fight the disease.
What to Expect on the Day of Treatment
Benefits of Provenge for Prostate Cancer
Risks of Provenge
Most side effects are mild to moderate and last only 1 to 2 days.
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Immunotherapy For Prostate Cancer
Cancer vaccines and checkpoint inhibitors are approved immunotherapies for prostate cancer. CAR T-cell therapy is a new treatment that doctors are learning more about in clinical trials.
You might be a good candidate for one of these treatments if your cancer didn’t stop growing or it came back after surgery or hormone therapy. Immunotherapy could help some people with prostate cancer live longer, but it does have some risks to discuss with your doctor.
Finding Small Amounts Of Prostate Cancer Using Imaging And Psma
NCI-supported researchers are developing new imaging techniques to improve the diagnosis of recurrent prostate cancer. A protein called prostate-specific membrane antigen is found in large amountsand almost exclusivelyon prostate cells. By fusing a molecule that binds to PSMA to a compound used in PET scan imaging, scientists have been able to see tiny deposits of prostate cancer that are too small to be detected by regular imaging. The Food and Drug Administration has approved two such compounds for use in PET imaging of men with prostate cancer.
This type of test is still experimental. But the ability to detect very small amounts of metastatic prostate cancer could help doctors and patients make better-informed treatment decisions. For example, if metastatic cancer is found when a man is first diagnosed, he may choose an alternative to surgery because the cancer has already spread. Or doctors may be able to treat cancer recurrenceeither in the prostate or metastatic diseaseearlier, which may lead to better survival.
As part of the Cancer Moonshot, NCI researchers are testing whether PSMA-PET imaging can also identify men who are at high risk of their cancer recurring. Such imaging may eventually be able to help predict who needs more aggressive treatmentsuch as radiation therapy in addition to surgeryafter diagnosis.
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Cancer Research Led To Speedy Development Of Mrna Vaccines
When the pandemic struck, mRNA vaccine technology had an unexpected opportunity to demonstrate its promise, said Norbert Pardi, Ph.D., of the University of Pennsylvania Perelman School of Medicine, whose research focuses on mRNA-based vaccines.
The production of mRNA vaccines today is easy, fast, and can be scaled up as needed, Dr. Pardi continued. The same manufacturing procedure can be applied to any mRNA sequence, he added.
Historically, the process of developing vaccines has taken 10 to 15 years. But both the Pfizer-BioNTech and the Moderna COVID-19 vaccinesthe latter of which was developed in collaboration with NIHwere designed, manufactured, and shown to be safe and effective in people in less than a year.
To develop an infectious disease vaccine during a pandemic, you need to be fast, said Lena Kranz, Ph.D., co-director of Cancer Vaccines at BioNTech. The current pandemic has confirmed our hypothesis that mRNA technology is well suited for fast vaccine development and rapid manufacturing on a global scale.
The groundwork for the speedy design, manufacturing, and testing of the mRNA COVID-19 vaccines was established through decades of work on cancer vaccines. During this period, immunotherapy, including drugs such as immune checkpoint inhibitors, emerged as a new approach to treating cancer, leading, in some people, to dramatic and long-lasting responses.
Advancing The Science Of Mrna Cancer Vaccines
A lot of immunotherapies stimulate the immune response in a nonspecific waythat is, not directly against the cancer, said Dr. Ott. Personalized cancer vaccines can direct the immune response to exactly where it needs to be.
Some companies are also investigating mRNA cancer vaccines that are based on collections of a few dozen neoantigens that have been linked with certain types of cancer, including prostate cancer, gastrointestinal cancers, and melanoma.
In addition to clinical trials, fundamental research on mRNA cancer vaccines continues. Some investigators are trying to enhance the responses of immune cells to neoantigens in mRNA vaccines. One study, for example, aims to improve the responses of T cells that become exhausted while attacking tumors.
A challenge for the field is learning how best to identify neoantigens for personalized mRNA cancer vaccines, several researchers said.
Theres still a lot we need to learn and many questions to answer, Dr. Ott said. Its not yet clear, for example, how personalized cancer vaccines should be best combined with other treatments, such as immune checkpoint inhibitors, he added.
As cancer researchers pursue these questions, other investigators will be developing knowledge from the growing number of people around the world who are receiving mRNA coronavirus vaccines.
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