- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03194516
Ketogenic Diet and Prostate Cancer Surveillance Pilot (GCC 1717)
A Ketogenic Diet Pilot Study for Overweight Prostate Cancer Patients on Active Surveillance
Visão geral do estudo
Descrição detalhada
More than 1.6 million new cases of cancer are estimated in the United States in 2016, with almost 600,000 individuals dying from the disease. Prostate cancer alone is responsible for 180,000 new diagnoses per year and remains the most common new cancer diagnosis for men.
Current treatment options for prostate cancer include surgery, radiation, high-intensity focused ultrasound, and cryotherapy. Although typically successful, these strategies carry significant risks for incontinence, erectile dysfunction, and local tissue injury. As a result, for a select subgroup of men with more indolent forms of prostate cancer, active surveillance has become the preferred management strategy. This approach entails periodic laboratory testing, with prostate-specific antigen (PSA) checks at intervals of 3-6 months, and repeat prostate biopsies every 1-2 years or earlier if indicated by PSA elevations. Treatment interventions are typically withheld unless re-biopsy results indicate progression to more aggressive disease. Prospective data comparing surgery and active surveillance have demonstrated improved quality of life outcomes with the latter approach . Not surprisingly, national registry data shows that active surveillance usage has increased from <15% between 1990 and 2009 to >40% between 2010 and 2013 for eligible patients . In order to ensure proper patient selection for active surveillance, MRI guided confirmation biopsies have become standard of care options. Almost one-third of patients will be found to harbor more aggressive cancer than revealed by their initial biopsy. Ideally, treatment could be delayed indefinitely for properly selected patients.
Although surveillance offers a reprieve from cancer treatment and its potential negative sequelae, this benefit appears temporary for many men. Institutional cohort data indicate that 36%-55% of men on active surveillance will require treatment for disease progression within 10 years. One notable risk factor for disease progression during surveillance is overweight and obesity. In a study of 565 prostate cancer patients on surveillance, a 50% increased risk of pathologic progression was associated with every 5 kg/m2 increase in BMI over 25. These results support additional evidence linking weight gain with an increased risk of prostate cancer recurrence after surgery. They have also prompted studies examining pre-surgical weight loss using caloric restriction to mitigate the risk associated with obesity. A low carbohydrate, ketogenic approach has been previously studied in small samples of patients with other types of cancer and also proposed for prostate cancer patients.
In brief, a ketogenic diet is a high-fat, low-carbohydrate diet that mimics the metabolic state of long-term fasting. Ketone bodies are generated mainly by ketogenesis in the mitochondrial matrix of liver cells and are subsequently exported via the blood to other organs to cover the energy demands of cells throughout the body. Ketogenic deaminated amino acids such as leucine also feed the citric acid cycle to form ketone bodies. Utilization of a ketogenic diet as an adjuvant prostate cancer therapy is particularly intriguing given recent preclinical data demonstrating that ketones function as endogenous histone deacetylase (HDAC) inhibitors. HDAC inhibitors have been shown to inhibit prostate cancer proliferation in preclinical models, and are already being studied in clinical trials. Therefore, the ketogenic diet may have a direct impact on disease progression that may extend beyond the BMI reduction achievable by caloric restriction, exercise or other weight loss strategies.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland GCCC
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Male Adults ≥ 18 years of age
- New biopsy proven prostate adenocarcinoma meeting NCCN guidelines for active surveillance OR previously diagnosed prostate cancer patients on active surveillance
- Eastern Cancer Oncology Group performance status ≤2
- Life expectancy > 1 year
- BMI ≥ 25 kg/m2
Exclusion Criteria:
- Diabetes mellitus on diabetes medication or insulin therapy
- Prior completion of MRI guided confirmation prostate biopsy
- Use of hormonal therapy including finasteride in the past 6 months
- Concomitant use of oral glucocorticosteroids
- Cholecystectomy within 1 year prior to study entry
- Symptoms requiring immediate surgical intervention or radiation therapy
- Active malignancy other than prostate cancer requiring therapy other than non-melanomatous skin cancers
- Participation in any clinical research study evaluating an investigational drug or therapy within one month prior to enrollment
- Any condition that in the judgment of the investigators would interfere with the subject's ability to comply with the study procedures, tolerate the dietary protocol or interfere with the evaluation of responses
- Unable or unwilling to provide informed consent
- Must not be a female of any age
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Perda de peso
Prazo: 8 semanas
|
8 semanas
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Changes in Testosterone Level
Prazo: 8 weeks
|
8 weeks
|
Changes in Estrogen Level
Prazo: 8 weeks
|
8 weeks
|
Changes in TNF-Alpha Level
Prazo: 8 weeks
|
8 weeks
|
Changes in C-Reactive Protein Level
Prazo: 8 weeks
|
8 weeks
|
Changes in PSA Level
Prazo: 8 weeks
|
8 weeks
|
Changes in High Density Lipoprotein (HDL)
Prazo: 8 weeks
|
8 weeks
|
Changes in Low Density Lipoprotein (LDL)
Prazo: 8 weeks
|
8 weeks
|
Changes in Triglyceride Level
Prazo: 8 weeks
|
8 weeks
|
Changes in Total Cholesterol Level
Prazo: 8 weeks
|
8 weeks
|
Changes in Fasting Glucose Level
Prazo: 8 weeks
|
8 weeks
|
Changes in Leptin Level
Prazo: 8 weeks
|
8 weeks
|
Changes in Fasting Insulin Level
Prazo: 8 weeks
|
8 weeks
|
Changes in Prostate Tissue Metabolomic Profile
Prazo: 8 weeks
|
8 weeks
|
Changes in Prostate Tissue DNA Methylation
Prazo: 8 weeks
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adeel Kaiser, MD, Assistant Professor
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HP-00072961
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Câncer de próstata
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)ConcluídoSobrevivente de cancerEstados Unidos, Guam
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute of Mental Health (NIMH)ConcluídoSobrevivente de cancerEstados Unidos
-
Masonic Cancer Center, University of MinnesotaConcluídoSobrevivente de cancerEstados Unidos
-
Abramson Cancer Center of the University of PennsylvaniaConcluídoPlano de cuidados de sobrevivência LIVESTRONG: coleta contínua de dados e pesquisa de acompanhamentoPaciente com cancerEstados Unidos
-
University of New MexicoNew Mexico State University; University of New Mexico Cancer CenterConcluído
-
Ohio State University Comprehensive Cancer CenterConcluídoSobrevivente de cancerEstados Unidos