Effectiveness and Safety of Firmagon®
Androgen Ablative Therapy of Advanced Hormone-dependent Prostate CarcinomaEffectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA) progression during the Firmagon® therapy is to be documented and related to the testosterone values measured in the course of therapy (if available). Other clinical parameters, the patients' quality of life and the direct and indirect costs incurred by the medical care for the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In this context the medical outcome and the life quality are defined as effectiveness and benefit value parameters. Both the effectiveness under daily life circumstances and economic variables of the therapy can thus be shown and compared within an analysis of costs vs. benefits or costs vs. effectiveness.
Lycopene in Preventing Prostate Cancer in Healthy Participants
Prostate CancerRATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming. PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.
Identification of Prostate Cancer Genes
Prostate CancerThis study will identify genes that predispose men to prostate cancer and affect the rate and type of disease spread, the aggressiveness of the disease, and the long-term outcome. Several studies show there is a genetic component to prostate cancer susceptibility, and that a first-degree relative with prostate cancer increases a man's risk 2- to 3-fold compared to those without a family history. The risk is significantly higher if the relative was diagnosed at younger than 65 years of age, or if three or more first-degree relatives are affected. The study will try to locate prostate cancer genes in DNA samples using two methods: linkage analysis and association studies. Traditionally, the search for a disease gene begins with linkage analysis, in which the aim is to find the rough location of the gene relative to another DNA sequence, called a "genetic marker," whose position is already known. In genetic association studies, genes from a large number of patients are compared with healthy controls who are matched by age, race, and geographic region. DNA samples for this study come from patients in the two following studies at the Fred Hutchinson Cancer Research Center, Seattle, Washington: Family study: Participants are families with prostate cancer who have: 1) three or more first-degree relatives with prostate cancer; 2) three generations with prostrate cancer either through the maternal or paternal side of the family; or 3) two first-degree relatives with prostate cancer diagnosed before age 65 or who were African American. Population-based study: Participants are patients with prostate cancer and matched healthy control subjects. The identification of prostate cancer genes important in susceptibility to the disease and its aggressiveness may permit earlier detection and development of more directed and effective treatments based on underlying genetics.
Prostate Biomarker Study
Prostate CancerRadical Prostatectomy (removal of the prostate) or radiation therapy provide excellent outcomes for patients with localized (confined to one area) disease, yet there is still no effective treatment once the disease has spread beyond the prostate gland. Typically, a serum PSA test is done to diagnose prostate cancer. Following diagnosis, a prostate biopsy and other tests help to classify the patient's disease according to the likelihood of a recurrence. However, these assessments are imperfect. There is a need to identify and evaluate prostate biomarkers that will provide exact information regarding the likelihood of a recurrence (prediction) of prostate cancer.
Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation...
Prostate CancerThe purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.
Investigating the Impact of Tailored Reports on Anxiety Amongst Cancer Patients and Their Confidants...
Breast NeoplasmsProstatic Neoplasms2 moreObjective: To explore the hypothesis that different methods of selecting and printing information for cancer patients could improve emotional support by affecting interaction with others, and so lead to improved psychological wellbeing. Design: Randomised trial with 8 groups (three factors, 2X2X2). Data collected at recruitment and three month follow-up. Participants: 400 patients starting radiotherapy and their 'confidant' (the person in who they confide). Interventions: Printed booklets. Half had 'general' CancerBACUP information for that cancer; half had 'personal' information from the medical record plus selected general information; Half chose information by 'interacting' with the computer; half had a larger volume of material in booklets that were produced 'automatically'. Half had additional 'anxiety management advice'. Outcomes: Patients' views; use of booklet with others; change in reported social support; change in anxiety and depression.
Gene Mutations in Patients With Advanced Prostate Cancer That Is Not Responsive to Hormone Therapy...
Prostate CancerRATIONALE: Gene mutations may make prostate cancer cells unable to attach to androgens. This may permit the growth of prostate cancer. Gene testing may improve the identification of patients with advanced prostate cancer. PURPOSE: Clinical trial to study the androgen receptor gene in patients with prostate cancer that is not responsive to hormone therapy.
Study of Prostate Cancer in Black and White U.S. Veterans
Prostate CancerProstatic NeoplasmsProstate cancer is diagnosed in approximately 334,500 men each year and accounts for nearly 41,800 deaths in the United States. Prostate cancer is the leading cancer affecting veterans and the second leading cancer among all Americans. The causes of prostate cancer and, particularly, the reasons for the unusually high incidence rates in African-Americans remain obscure. Dietary factors likely play a role in fatal cases, while hormones are also important in regulating prostate cancer growth. Dr. Charles Huggins recognized this effect in the 1940?s, with androgen deprivation remaining as the cornerstone of therapy for advanced disease. Despite the strong circumstantial evidence, neither epidemiologic studies nor basic sciences have produced clear insight into the etiologic role of hormones. However, recent observations regarding androgen receptor gene polymorphisms and their relation to endocrine expression and prostate cancer risk may be providing important clues as to how an etiologic role might be mediated at the molecular level. Thus, it is important to attempt to identify genetic markers of high-risk cancer patients for necessary screening and counseling efforts.
Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis...
Prostate Cancer MetastaticRadiotherapy Side Effect5 moreSystemic therapy (i.e Androgen Deprivation Therapy with Docetaxel, Enzalutamide, Apalutamide or Abiraterone Acetate) has increased overall survival in men with hormone-sensitive metastatic prostate cancer. Novel local cytoreductive treatments and metastasis directed therapy are being evaluated, these can confer additional harm, but might improve survival. We aim to elicit men's preferences for and willingness to accept trade-offs between potential improved survival and cytoreductive treatment risks using a 'discrete choice experiment'.
Stockholm3 Validation Study in a Multi-Ethnic Cohort
Prostate Cancer (Diagnosis)Introduction: Prostate cancer (PCa) is the most commonly detected cancer in men and is the second leading cause of cancer death. Differences in race and ethnicity have been shown to have differences in PCa incidence, detection, and outcomes. Current prostate cancer screening involves prostatic specific antigen (PSA) which is a nonspecific protein marker (aka kallikrein) that can often leads to unnecessary biopsies (up to 74% benign biopsies) and clinical overdiagnosis (with up to 22% clinically insignificant cancer). Recently more sophisticated tests have been developed for PCa screening in the United States such as the Prostate Health Index (PHI) and the 4k (kallikrein) score, as well as clinical models that use information from the patient clinical history. However, these tests utilize limited serum protein assays and none of the established screening protocols utilize genetic variables to help account for the likely inherited risks as seen in different ethnicities. A recent Swedish, prospective, population-based study, published in the Lancet Oncology, developed a unique multivariable biopsy outcome prediction model within a Nordic population of nearly 60,000 men. This model, the Stockholm3, which incorporated plasma protein markers, germline DNA SNPs as well as clinical variables, was shown to be capable of reducing the number of biopsies by 44% compared to PSA while maintaining adequate sensitivity for detection of PCa. It is unknown whether an approach developed in Sweden that incorporates protein markers, genetics, clinical variables, and genetic ancestry would be beneficial in a racially diverse cohort. Hypothesis: The investigators hypothesize that, a prospectively studied multiethnic cohort of men with the Stockholm3 test will identify unique and common risk factors that improve prostate cancer detection. Aim: To assess the performance of the Stockholm3 test as compared to PSA and to identify unique features associated with PCa in Black/African American (n=500), Asian (n=500), White/Caucasian Hispanic (n=500), and White/Caucasian Non-Hispanic (n=500) men. Methods: The investigators propose a prospectively identified cohort with participating institutions which have screened positive to undergo a prostate biopsy to have a retrospective analysis the Stockholm3 test and ancestry markers. Within this cohort the investigators will examine several predetermined risk factors to investigate their relationship to prostate cancer. This blood sample will be tested for quantitative levels of serum protein markers and DNA will be extracted and will be tested for germline mutations as defined by the Stockholm3 test and other ancestry informative markers. Results from the study will be presented in such a way that no individual information will be disclosed.