29 Clinical Trials for Various Conditions
The purpose of this study is to study the molecular effects of the chemopreventative agent, finasteride, in combination with dietary soy supplementation in patients at high risk for the development of prostate cancer. Also, the investigators intend to create a large database with health information from men who are at high risk of developing prostate cancer, along with serum and tissue samples from those patients who are willing to provide tissue and serum samples.
Studies on patterns of how many men get prostate cancer in other countries show that environment contributes to the high incidence of prostate cancer in the United States. Epidemiology studies suggest that this influence may be reduced by the diet of men at risk of getting prostate cancer. Although the exact nature of the effects of diet are not completely known, the amount of fat eaten appears to affect the number of men who get prostate cancer. The type of fat also seems to matter. Eating more of a type of fat called omega-3 polyunsaturated fat is associated with decreased prostate cancer risk. Omega-3 fat comes from fish and is quite different from the type of fat from animals and vegetables (omega-6 fat). Because the exact mechanism of this reduction in prostate cancer risk is not known, no blood test indications, called markers, have been discovered that would show the effect working. Study doctors designed this study to try to find markers in the blood tests of men who have prostate cancer, and to find out if a diet supplemented with omega-3 type fat from fish oil helps reduce those markers, hence indicating that it helps reduce the cancer in these men. These men will be compared to men with prostate cancer whose diets do not contain the fish-oil fat. The men chosen will have prostate cancer and be scheduled for operations to have their prostate glands removed. They will be chosen randomly to be given the fish-oil diet or a regular Western diet for comparison for 4 to 8 weeks. Their blood will be checked at the beginning of the diet. After the 4-to-8-week period, they will have their operations. Their blood will be checked again and a sample of their removed prostate will be examined to tell if the diet had any effect on the cancer and its markers.
The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).
The objective of the study is to identify mechanisms by which compounds found in cruciferous vegetables alter gene expression via epigenetic modifications (changes in gene expression) and may prevent prostate cancer development. The investigators have found that sulforaphane (SFN), an isothiocyanate found in cruciferous vegetables, inhibits histone deacetylase (HDAC) activity in human colorectal and prostate cancer cells.
The purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to prevent the development of cancer. Flutamide may be effective in the prevention of prostate cancer. PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate.
This proposal brings together multidisciplinary teams from four New York City institutions charged with reducing cancer disparities that affect approximately two million people residing in some of the most diverse and underserved communities in the United States. The intent of this collaborative research is captured by its acronym, DISRUPT: Diversity \& IncluSion in Research Underpinning Prevention \& Therapy Trials. To disrupt the norms that maintain heightened risk and poorer outcomes experienced by BIPOC, the research team propose three integrated and synergistic aims to improve diversity and inclusion in CTs through disruptive approaches at the community (Aim 1), provider, system and patient (Aim 2), and basic and translational scientist levels (Aim 3). All three aims focus on metrics for changing norms reified in institutional policies and established practice that will provide essential evidence to translate and scale these changes to institutions and networks involved in cancer treatment research. In Aim 1, the research team will partner with local organizations to formulate and disseminate new norms regarding cancer care and research and diffuse these new norms throughout the community via community organizations and Health Ambassadors bringing a different vantage point on CTs, raising awareness and increasing demand for access to cancer research. In Aim 2, the research team will create an electronic approach to identify key clinical characteristics of patients and trials and match patients and trials and bring these data to patients and their physicians at the time of key decisions. In Aim 3, the research team will provide and integrate essential experiential training in diversity, social determinants of health and the importance of conducting community-relevant work into basic and translational science training. This DISRUPT proposal provides the foundation to disrupt norms about cancer clinical trials in our communities, delivery systems and scientific research enterprises.
This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (RT) and androgen deprivation therapy (ADT). ADT effectively slows the growth of prostate cancer cells, thereby enhancing the therapeutic effectiveness of RT. Despite the clinical gains, ADT leads to an array of side effects including insulin resistance, abnormal lipid levels, weight gain, increased visceral fat mass coupled with increased muscle wasting, and quality of life deterioration. A diet and physical activity intervention may intercept or prevent the abrupt metabolic and physiologic changes caused by androgen deprivation therapy in prostate cancer patients receiving ADT and RT.
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
This early phase I trial studies the feasibility of a daily, long-term intermittent fasting routine in preventing or delaying a rise in prostate specific antigen (PSA) levels in patients with prostate cancer that has not spread to other parts of the body (localized) and who have undergone radical prostatectomy. PSA is a protein produced by both normal and cancer cells. Following a daily fasting routine after treatment for prostate cancer may lower the risk of patients' PSA level rising above 0.4 ng/mL, which is also called PSA-recurrence. A PSA-recurrence can sometimes mean that the disease has returned and/or progressed.
The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP).
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of the instrument. Their use in this study will be to perform tissue transection during PLND such that the intended use is within the FDA-approved domain for this instrument. Investigators intend to identify whether its use for PLND reduces lymphoceles given that the device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels encountered during PLND. Because the instrument is new and has been FDA approved for less than one year, there is no published literature regarding its use to date. Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the incidence of screening detected lymphoceles on that side. Investigators propose a total sample size of 120 patients.
The purpose of this study is to assess for changes in a patient's overall energy level and well-being (quality of life) after 8 weeks of dietary intervention.
The purpose of this study is to discover if intensive lifestyle changes (such as diet and increased physical activity) improve the body's sensitivity to insulin, and therefore help prevent diabetes and other cardiovascular disease, in men receiving GnRH hormone therapy for prostate cancer.
Participants will be diagnosed with localized prostate or breast cancer and be scheduled to undergo external beam radiation therapy. Participants will either receive a placebo or organic germanium to be taken 5 times a day starting the day of their first radiation and continuing through the 1 month follow-up visit. Weekly Quality of life forms will be completed through the one month follow up visit and then at the 3 month follow up visit. Labs will be done prior to the start of treatment, at the end of treatment and at the one and three month follow-up visits.
The Centers for Medicare and Medicaid Services (CMS) has awarded cooperative agreements to 6 sites from across the country (Salt Lake City, UT, Molokai, HI, Houston, TX, Newark, NJ, Detroit, MI, and Baltimore City) to participate in a national 4-year demonstration (September 15, 2006 to September 30, 2010). One goal of the demonstration is to reduce disparities in cancer treatment among seniors from U.S. racial and ethnic minority populations. Each site will focus on a specific racial/ethnic minority group, and collaborate with CMS in project implementation. A Core questionnaire, the Cancer Screening Assessment (CSA) will be administered at baseline to all participants in the demonstration. Participant identification, randomization, and intervention implementation will be standardized across sites. Goal: The proposal developed by the Johns Hopkins Bloomberg School of Public Health in collaboration with the Baltimore City Community Health Coalition is designed to address persistent disparities in breast, cervix, colon/rectum, prostate and lung cancer treatment. Primary Objective: Conduct A CONTROL RANDOMIZED TRIAL within a randomized control demonstration project (N = 200) to compare the efficacy of 2 interventions that differ in intensity to improve continuity and outcomes of care among African Americans seniors. Among African American seniors, compared to a less intensive intervention (general information and educational materials), does the addition of facilitation services delivered by a health coordinator result in a greater improvement in adherence to recommended treatment among those diagnosed with breast, cervix, colon/rectum, prostate, or lung cancer? Study Population: We will recruit African Americans, age 65 years or older, and currently enrolled in Medicare Parts A and B. (Baltimore City's 82,202 seniors represent 13% of its population, and account for 68% of the City's cancer deaths. Among these seniors, 96% have Medicare Parts A and B, 54.5% have income levels at less than 250% of the federal poverty guideline, and 55.6% are African American.) The trial consists of individuals diagnosed with breast, cervical, colorectal, prostate, or lung cancer. Eligible participants will respond to a baseline questionnaire, the Cancer Screening Assessment (CSA). They will then be randomized to receive a less intensive or more intensive intervention. The less intensive group will receive general information about cancer and Medicare covered services and instructions to discuss the information with their primary care doctor. The more intensive group will receive the same information as the less intensive group receives, plus tailored facilitation services delivered by a nurse-supervised community health worker. The primary outcome variable for the trial will be the difference between randomized groups in adherence to treatment for breast, cervix, colon/rectum, prostate and lung cancer. A community advisory committee will guide all aspects of the study and will include important stake holders (both public and private sectors), representatives from the Baltimore City Community Health Coalition, the Baltimore City Department of Health, the Maryland Department of Health and Mental Hygiene, community leaders, consumers, health care providers (physicians, oncologists, nurse practitioners, physician assistants, nurses, social workers, pathologists) and academicians.
The goal of this behavioral research study is to improve the use of cancer prevention services, increase early detection, and treatment of cancer. A secondary outcome of this demonstration project proposes that a structured patient navigator (PN) will reduce the cost of Medicare services.
The overall goal of this proposal is to determine the effectiveness and safety of once weekly alendronate (Fosamax) in the prevention and treatment of osteoporosis in men with prostate cancer on androgen deprivation therapy and to evaluate maintenance of bone mass following termination of therapy after one year.
Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.
The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
The purpose of this two year study is to examine the safety and effectiveness of alendronate (Fosamax) for the prevention of bone loss in men with prostate cancer who are on therapy to lower their testosterone levels. All men will receive appropriate calcium and vitamin D supplements and one to two years of alendronate therapy. Bone density tests will be done every six months.
This Pilot Study is to investigate the tear proteins in a multitude of cancer types and indulge in biomarker discovery to manufacture simple, accurate, and novel tear-based diagnostic tests.
Diagnostic delays in ambulatory care are often due to breakdowns of related care processes. Electronic systems can improve follow-up and reduce delays by detecting missed appointments or incomplete procedures so that patients are called back to conduct timely investigations when appropriate. To achieve high standards of patient safety in cancer diagnosis, the investigators not only need to use information technology appropriately but also improve the processes, policies, and procedures of monitoring, communication, and coordination of care. Given the importance of cancer-related diagnostic delays in ambulatory care, the investigators need effective methods to detect them, understand their causes, and intervene to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and random chart reviews, have limited effectiveness. Our proposed study focuses on testing methods to proactively identify delays using certain "triggers" as they occur and intervene in a timely manner.
Objectives: The primary objective of the research project is to investigate how declining health status influences the end-of-life (EOL) treatment preferences in Latino Medicare beneficiaries with cancer and to examine if and how these preferences are modified by predisposing characteristics (i.e., acculturation, education, medical mistrust, perceived racism) and/or provider-related characteristics (i.e., ethnicity, language used, provision of interpreters, or patient navigators). The specific aims are: 1. To determine if declining functional status influences the end-of-life treatment preferences of older Latino Medicare beneficiaries with cancer. 2. To determine if predisposing characteristics (i.e., acculturation, age, education, medical mistrust, perceived racism) and/or provider-related characteristics (i.e., ethnicity, language used, provision of interpreters, or patient navigators) modify the association between end-of-life treatment preferences and declining health status in older Latino Medicare beneficiaries with cancer. 3. To identify if the end-of-life treatment preferences of Latino Medicare beneficiaries with cancer differ from those of older Medicare beneficiaries without cancer.
This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.