Abstract:
INTRODUCTION:Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control. Large multi-centre trials are required to evaluate medium-term cancer control and reproduce functional recovery. We describe the study design of an investigator-led UK multi-centre, single arm trial using HIFU to deliver focal therapy for men with localised prostate cancer. METHODS:One-hundred and forty men with histologically proven localised low or intermediate risk prostate cancer (PSA < 15, Gleason ≤ 7, ≤ T2cN0M0) will undergo precise characterisation of the prostate using a combination of multi-parametric (mp)MRI and transperineal template prostate mapping (TPM) biopsies. Unilateral dominant tumours, the so-called index lesion, will be eligible for treatment provided the contra-lateral side is free of 'clinically significant' disease (as defined by Gleason ≥ 7 or maximum cancer core length ≥4 mm). Patients will receive focal therapy using HIFU (Sonablate 500®). Treatment effect will be assessed by targeted biopsies of the treated area and TPM biopsies at 36-months. RESULTS:Primary outcome is the absence of clinically significant disease based on 36-month post-treatment TPM biopsies. Secondary outcomes address a) genitourinary function using validated patient questionnaires (IPSS, IPSS-QoL, IIEF-15, EPIC-Urinary, EPIC-Bowel, FACT-P, EQ-5D), b) the predictive validity of imaging, and c) risk factors for treatment failure. CONCLUSIONS:INDEX will be the first multi-centre, medium term follow-up trial to evaluate the outcomes of a tissue preserving strategy for men with localised prostate cancer using the TPM-ablate-TPM strategy.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Dickinson L,Ahmed HU,Kirkham AP,Allen C,Freeman A,Barber J,Hindley RG,Leslie T,Ogden C,Persad R,Winkler MH,Emberton M,INDEX Study Group.doi
10.1016/j.cct.2013.06.005subject
Has Abstractpub_date
2013-09-01 00:00:00pages
68-80issue
1eissn
1551-7144issn
1559-2030pii
S1551-7144(13)00097-9journal_volume
36pub_type
杂志文章,多中心研究abstract:BACKGROUND:Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis. METHODS: EXPOSURE:Randomization to cin...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.04.001
更新日期:2016-05-01 00:00:00
abstract::Evaluation of time to event outcomes usually is examined by the Kaplan-Meier method and Cox proportional hazards models. We developed a modified statistical model based on histologic grade and other variables to describe the time-dependent outcome for autologous stem cell transplant (autotransplant) performed for non-...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.07.005
更新日期:2008-03-01 00:00:00
abstract::There are few effective obesity interventions directed towards younger children, particularly young minority children. This paper describes the design, intervention, recruitment methods, and baseline data of the ongoing Positive Lifestyles for Active Youngsters (Team PLAY) study. This randomized controlled trial is de...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.02.003
更新日期:2012-05-01 00:00:00
abstract::An instrumental variable (IV) estimator has been widely used to estimate causal effects among compliers in randomized trials with noncompliance. The estimator of complier average treatment effect can be expressed as a ratio of two unbiased estimators but the ratio estimator is not unbiased. The bias of IV estimator ca...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.03.013
更新日期:2012-07-01 00:00:00
abstract::Hepatitis C virus (HCV) is a leading cause of chronic liver disease. The natural history of HCV infection is heterogeneous, and a person infected with HCV can clear the virus or progress to a chronic infection. The chronic infection can remain asymptomatic for decades before the development of liver cirrhosis and/or c...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2008.03.006
更新日期:2008-09-01 00:00:00
abstract::Caregivers for a family member with dementia experience chronic long-term stress that may benefit from new complementary therapies such as mindfulness-based stress reduction. Little is known however, about the challenges of recruiting and retaining family caregivers to research on mind-body based complementary therapi...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2011.05.002
更新日期:2011-09-01 00:00:00
abstract:BACKGROUND:Evaluation of new therapies for cancer has suffered a paradigm shift in the last years. The use of innovative and more efficient designs is a priority for the scientific community; nevertheless, the use of this kind of design is not yet wide spread. PURPOSE:In this paper will examine the effectiveness of ad...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2011.09.017
更新日期:2012-01-01 00:00:00
abstract:OBJECTIVE:Feasibility of a clinical-trial comparing a low-glycaemic diet with a low-calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with PCOS. DESIGN:A pilot Randomised-Controlled-Trial using different recruitment strategies. SETTING:A University Hospital ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.05.001
更新日期:2009-09-01 00:00:00
abstract:BACKGROUND:Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families. METHODS:This ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.12.010
更新日期:2019-02-01 00:00:00
abstract::Dosing is potentially the most important decision that must be made when building or refining behavioral interventions. In this paper, we propose standardized terminology and reporting of dosing information, which would inform intervention development, refinement for dissemination, and systematic reviews of dose-respo...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2012.07.011
更新日期:2012-11-01 00:00:00
abstract::The use of blinding strengthens the credibility of randomized controlled trials (RCTs) by minimizing bias. However, there is confusion surrounding the definition of blinding as well as the terms single, double, and triple blind. It has been suggested that these terms should be discontinued due to their broad misinterp...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2010.11.004
更新日期:2011-03-01 00:00:00
abstract::The Ready Steady 3.0 trial is designed to test the main and interactive effects of two behavior change intervention components, within an 8-week physical activity intervention, on older adults' physical activity (PA). Each component is comprised of behavior change strategies that emphasize two different evidence-based...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106238
更新日期:2020-12-05 00:00:00
abstract:BACKGROUND:Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25-32 years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully qui...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.06.001
更新日期:2019-08-01 00:00:00
abstract:INTRODUCTION:In promoting the health of chronically ill children, the hospital should help children cope both medically and psychosocially with their disease. The University Children's Hospital of Nancy proposes adapted physical activity for hospitalized children, but the practice during hospitalization is not well dev...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.12.003
更新日期:2010-03-01 00:00:00
abstract:BACKGROUND:Many of the health behaviors known to contribute to cardiometabolic risk and disease (CMRD), including physical activity, diet, sleep, and screen time, begin during childhood. Given the population-wide burden of CMRD, novel ways of assessing risk and providing feedback to support behavior change are needed. ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.07.012
更新日期:2016-07-01 00:00:00
abstract:BACKGROUND:Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been eval...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2013.08.001
更新日期:2013-11-01 00:00:00
abstract::Home-based telemedicine (HBT) is a validated method of evidence-based treatment delivery for posttraumatic stress disorder (PTSD), and justification for its use has centered on closing gaps related to provider availability and distance to treatment centers. However, another potential use of HBT may be to overcome barr...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.03.004
更新日期:2016-05-01 00:00:00
abstract::Osteoarthritis (OA) is the most common chronic condition and principal cause of disability among older adults. The current obesity epidemic has contributed to this high prevalence rate. Fortunately both OA symptoms and obesity can be ameliorated through lifestyle modifications. Physical activity (PA) combined with wei...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.11.014
更新日期:2014-03-01 00:00:00
abstract::Researchers have long sought to find combinations of cancer drugs that might achieve synergy. However, while observed in some preclinical tumor models, synergistic effects are rarely seen in clinical trials. In fact, growing evidence in clinical trial data shows that the treatment effect of most approved combination t...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106126
更新日期:2020-11-01 00:00:00
abstract::In order to better characterize the safety profile of investigational new drugs (INDs) during clinical development, more interest and attention have been paid to ongoing safety monitoring and evaluation. The 2015 US FDA IND safety reporting draft guidance compels sponsors to periodically evaluate unblinded safety data...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.06.022
更新日期:2019-08-01 00:00:00
abstract:BACKGROUND:Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. OBJECTIVES:The Home Blood Pressure Telemonitorin...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.03.014
更新日期:2012-07-01 00:00:00
abstract:BACKGROUND:Functional dyspepsia (FD) is a common problem affecting up to 10-25% of individuals. FD accounts for significant health care costs and affects quality of life but has no definitive treatment. OBJECTIVES:The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (am...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.02.002
更新日期:2012-05-01 00:00:00
abstract::Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Br...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.06.005
更新日期:2016-07-01 00:00:00
abstract:INTRODUCTION:Breast cancer survivors face dual challenges: long term sequelae of treatment, and risk of recurrent disease. Obesity and a sedentary lifestyle complicate both challenges. The WISER Survivor trial assessed the effects of exercise and/or weight-loss on lymphedema, biomarkers of breast cancer recurrence, and...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.07.017
更新日期:2017-10-01 00:00:00
abstract:BACKGROUND:Children with sickle cell anemia (SCA) have an 11% risk of stroke by the age of 18. Chronic transfusion applied in patients detected to be at risk by transcranial Doppler allows a significant reduction of stroke risk. However, chronic transfusion exposes to several adverse events, including alloimmunization ...
journal_title:Contemporary clinical trials
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.cct.2017.08.008
更新日期:2017-11-01 00:00:00
abstract:BACKGROUND:This paper reports the protocol of a randomised, double-blind, placebo-controlled study to test the efficacy, safety, and tolerability of lubiprostone (LUB) vs. placebo on suppressing gut permeability in non-alcoholic fatty liver disease (NAFLD) patients with constipation. NAFLD, including non-alcoholic stea...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.04.002
更新日期:2018-06-01 00:00:00
abstract:BACKGROUND:Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and die...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.09.004
更新日期:2013-01-01 00:00:00
abstract:PURPOSE:African-American women (AAW) are more likely to be metabolically unhealthy than White women (WW). Metabolic syndrome (MetS) is associated with increased breast cancer risk and mortality from breast cancer is greater in AAW compared to WW. Data show MetS affects health-related quality of life (HRQoL). Exercise s...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.02.005
更新日期:2018-04-01 00:00:00
abstract:BACKGROUND:Postmenopausal Latinas are a growing population group in the US who are at high risk for cardiovascular disease. Epidemiological studies have shown that excessive sitting is related to cardiovascular disease risk. Older women sit for prolonged periods and most individuals do not meet physical activity guidel...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2019.02.004
更新日期:2019-04-01 00:00:00
abstract::The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2007.01.003
更新日期:2007-07-01 00:00:00