View clinical trials related to Metastatic Prostate Cancer.
Filter by:The purpose of this study is to assess the impact of the addition of metformin to abiraterone on survival in patients with metastatic prostate cancer
This is a randomized, double blind, multi-institutional phase II therapeutic study of Indoximod or placebo after the completion of standard of care sipuleucel-T (Provenge®) in men with asymptomatic or minimally symptomatic metastatic prostate cancer that is castration resistant (hormone refractory). Patients are randomized to receive either twice daily oral Indoximod or placebo for 6 months beginning the day after the third and final sipuleucel-T infusion.
This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) patients previously treated with docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include time to treatment failure, response rate, overall survival and quality of life.
This clinical trial will examine a novel combination of anti-OX40 to induce proliferation of memory and effector T cells in conjunction with cyclophosphamide (CTX) and radiation to induce tumor antigen release with the overall goal of promoting an immune response against prostate cancer.
Biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. Changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their cancer. It is hoped that serial measurement of these biomarkers may allow therapeutic monitoring in the future with successful individualisation of bisphosphonate therapy for metastatic prostate cancer.
The purpose of this research is to develop a new and powerful type of immune therapy for prostate cancer patients. This therapy involves vaccinations with special stimulator cells found in the human body called dendritic cells. These dendritic cells can take up proteins released from cancer cells and present pieces of these proteins to immune cells called T lymphocytes to create a strong stimulatory signal to fight the cancer. One of these proteins is called telomerase, which is found on prostate cancers and is critically important for prostate cancer cells to grow. However, in most cancer patients, the immune system does not adequately destroy the tumor because the T cells are not stimulated sufficiently. T cells require strong stimulation before they grow and become active against cancer cells. We have discovered that substances called ribonucleic acids (RNA), which carry the genetic instructions for the production of telomerase, can be used to overcome this problem and stimulate a strong immune response in cancer patients. In order to test this hypothesis we have designed a clinical study and will enroll patients with metastatic prostate cancer expressing telomerase in order to determine whether or not this vaccine will stimulate T cells, which can recognize and kill prostate tumor cells. The main objectives of this study are to find out whether injections with dendritic cells grown from blood cells and "pulsed" (mixed together for a short period of time) with RNA derived from the patient's own tumor are: 1. Safe without inducing any major side effects. 2. And effective in boosting the patient body's immunity against telomerase expressing prostate cancer cells. 3. Finally, we will test whether or not tumor shrinkage based on serum PSA levels or on X-ray studies will occur. We hope that this new form of immune therapy, although in its infancy, will ultimately slow down tumor growth and prolong survival of prostate cancer patients.
Bone is the most common site of metastases in prostate cancer and bone complications cause substantial morbidity to this population. Phase III studies have shown that zoledronic acid is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such treatment is high, and the risk of exposing patients (especially those at low risk) to potential serious side effects with uncertain benefit warrants investigation. This study will determine the duration of suppression of bone turnover in prostate cancer patients with bone metastases following a single infusion of Zoledronic Acid and its effect on quality of life.
RATIONALE : Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of prostate cancer.
Background: - Prednisone and docetaxel have been used successfully in treating patients with prostate cancer, either when used alone or in combination with other agents. Researchers believe that these anticancer effects can be increased by giving them in this specific combination. - A previous study at the National Cancer Institute combined docetaxel and prednisone with bevacizumab and thalidomide. The results of this study were promising; however, most patients in the study required a dose reduction of thalidomide because of its side effects. - Lenalidomide, a drug similar to thalidomide, may have less severe side effects. Based on previous studies, lenalidomide is well tolerated in patients with solid tumors when used alone or in combination with docetaxel, and it may be a good substitute for thalidomide. Objectives: - To determine if lenalidomide is an appropriate and effective substitute for thalidomide in treating prostate cancer. - To evaluate the safety and effectiveness of bevacizumab, lenalidomide, docetaxel, and prednisone as a prostate cancer treatment, and to study any side effects. Eligibility: - Men 18 years of age and older who have been diagnosed with metastatic prostate cancer that has not responded to standard treatment, including surgical removal of the testicles or treatment with androgen (sex-hormone) suppressing drugs. Design: - Participants will have a complete medical history and physical examination before beginning the study. - Patients will be treated with 21-day cycles with a combination of four drugs: - (1) Docetaxel, which will be given into a vein for 60 minutes on the first day of each 21-day cycle. Patients will take dexamethasone (a steroid agent) before and after taking docetaxel. - (2) Prednisone, which will be taken by mouth daily. - (3) Bevacizumab, which will be given through a vein over 30 to 90 minutes on the first day of each 21-day cycle following the infusion of docetaxel. - (4) Lenalidomide, which will be taken by mouth during the first 2 weeks of each 21-day cycle. The dose of lenalidomide may be adjusted if side effects develop. - Patients will also receive enoxaparin, a subcutaneous injection administered daily, to prevent blood clots and/or pegfilgrastim, a subcutaneous injection on day 2 of each cycle, to improve white blood cell counts, as directed by researchers.
Background: - It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role. - Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene. - Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others. Objectives: -To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state. Eligibility: -All participants participating in NCI prostate cancer protocols. Design: - Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic. - Blood samples are collected at the initial visit or at follow-up visits. - DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines. - Gene variations are correlated with prostate cancer prognosis and prognostic indicators.