TNFerade™ Biologic for Prostate Cancer
This study is evaluating whether a drug called TNFerade™ Biologic can improve the cure rate of prostate cancer.
See full descriptionAbout the trial for Prostate Cancer
Treatment Groups
This trial involves 2 different treatments. TNFerade™ Biologic is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Eligibility
This trial is for male patients of any age. There are 8 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Patient Q & A Section
How many people get prostate cancer a year in the United States?
About 1.07 million Americans will be diagnosed with prostate cancer annually. In men who are younger at diagnosis, the risk of death from prostate cancer is lower, whereas it is higher in men who are older at diagnosis. The risk of death from prostate cancer is also significantly higher in men who have a prior diagnosis of prostate cancer.
What causes prostate cancer?
Cancer is often seen as a product of the 'natural world'; ie. that the disease is caused by bad exposures such as smoking. However, while the body is able to remove some agents from the body, not all pollutants are removed. Tobacco smoke contains various carcinogens that are still in the body after smoking. Even though people who are not 'at risk' to developing [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are usually not advised of the risk caused by certain exposures (and/or are sometimes 'encouraged' not to smoke), there are many factors that are not adequately'removed' by the body's normal regulatory mechanisms. This is because some agents are not easily'removed' and/or cannot be'removed' at all.
What is prostate cancer?
Prostate cancer is often hard to distinguish from Benign Prostatic Hyperplasia. There are also a number of benign and malignant conditions that can be present for which a biopsy is required for definitive diagnosis. Treatment of prostate cancer involves a multidisciplinary approach. Treatment involves surgical intervention, hormonal treatment or radiation therapy following surgical intervention. If diagnosed early benign cases are treatable as well. The Gleason score, pathological grade and percentage of positive surgical margins are all important in predicting prognosis and treatment of prostate cancer.
What are common treatments for prostate cancer?
Prostate cancer is effectively treated through surgical surgery, radiation therapy, hormonal therapy, chemotherapy, and targeted therapy. The personalized needs of the individual will likely rely on the treatment that will be best for them and their family.
What are the signs of prostate cancer?
The diagnosis of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is made primarily on the basis of the physical examination of the rectum. Men who are experiencing discomfort related to BPH often are referred for a rectal examination to rule out the presence of a prostate cancer. The presence of a palpable lump on examination can also suggest prostate cancer. Other features that are suggestive of the existence of prostate cancer include an elevated PSA level, a family history of prostate cancer, and digital examination findings of the prostate gland. A prostate biopsy is the best means of definitively diagnosing prostate cancer. A biopsy can be helpful for defining a man's probability of having the disease, but it cannot determine whether or not the man actually has prostate cancer.
Can prostate cancer be cured?
Cancer can be successfully eradicated in a small proportion of men with early stage disease, but the majority will have biochemical and clinical failures and would require further therapy.
What are the common side effects of tnferade™ biologic?
The common side effect observed with tnferade™ is reversible neutropenia. The rate of neutropenia (3.2%) occurring in this study was more than twice lower than that reported with other biosimilars or monoclonals. Most cases of anemia and infusion-related reactions were transient and self-limiting. The incidence of infusion-related reactions, including chills, fever, nausea, and/or vomiting, was significantly lower than those reported with other biologics in the studies that evaluated tnferade™.
Is tnferade™ biologic typically used in combination with any other treatments?
Findings from a recent study is supporting combination of TNferade™ with cetuximab and with docetaxel, for the treatment of high-risk prostate cancer. We believe that the TNferade™ could be useful in the treatment of a high number of patients already treated with platinum-based drugs, or for the selection of patients that need combination chemotherapy.
Does tnferade™ biologic improve quality of life for those with prostate cancer?
The Tnferade™ biologic is an adjuvant therapy for patients with prostate cancer. Subjects on this biologic report meaningful improvements in physical and mental QOL similar to those seen in clinical trials. Because of the significant improvements in psychological QOL, this drug should be considered for patients who wish to engage in active, enjoyable experiences in the social, and hobby areas of their lives.
What are the latest developments in tnferade™ biologic for therapeutic use?
In an effort to develop a new, safer version of TNFα, researchers have looked into the use of TNFα in combination with conventional chemotherapy. Tumors are killed and cells are made sick as cytokines, but can cause complications when used continuously, even in small doses. A drug called TNFα may be a safer and more potent therapy than monoclonal TNFα antibodies. One experiment demonstrated that administering the cytokine in combination with chemotherapy killed a group of patients with a much higher rate of success than would have been anticipated with the monoclonal antibody treatments alone.
How serious can prostate cancer be?
It is important to understand that while some diagnoses may be serious, the majority of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s will resolve themselves without significant morbidity and mortality. The average age at diagnosis of prostate cancer is 70 years old and the long-term risks of treatment, including surgical and surgical.com or radiation therapies. The long-term morbidity is higher for radical treatments such as radical prostatectomy (RP) and radical cystoprostatectomy (RCP), especially when the disease has metastasised to the bones. The median duration of disease-free survival (DFS) following treatment depends on the level of disease aggressiveness, and the type of treatment.
What is the average age someone gets prostate cancer?
A substantial proportion of diagnosed men aged 50 or older (12.7%) are of Caucasian heritage (80% non-Hispanic white). Ethnic minority men and men of Chinese, Filipino, and Korean heritage have a higher prostate cancer incidence rate, compared to Caucasian men and African-American men.