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- Klinische proef NCT03194516
Ketogenic Diet and Prostate Cancer Surveillance Pilot (GCC 1717)
A Ketogenic Diet Pilot Study for Overweight Prostate Cancer Patients on Active Surveillance
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland GCCC
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Gewichtsverlies
Tijdsspanne: 8 weken
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8 weken
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Changes in Testosterone Level
Tijdsspanne: 8 weeks
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8 weeks
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Changes in Estrogen Level
Tijdsspanne: 8 weeks
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8 weeks
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Changes in TNF-Alpha Level
Tijdsspanne: 8 weeks
|
8 weeks
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Changes in C-Reactive Protein Level
Tijdsspanne: 8 weeks
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8 weeks
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Changes in PSA Level
Tijdsspanne: 8 weeks
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8 weeks
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Changes in High Density Lipoprotein (HDL)
Tijdsspanne: 8 weeks
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8 weeks
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Changes in Low Density Lipoprotein (LDL)
Tijdsspanne: 8 weeks
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8 weeks
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Changes in Triglyceride Level
Tijdsspanne: 8 weeks
|
8 weeks
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Changes in Total Cholesterol Level
Tijdsspanne: 8 weeks
|
8 weeks
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Changes in Fasting Glucose Level
Tijdsspanne: 8 weeks
|
8 weeks
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Changes in Leptin Level
Tijdsspanne: 8 weeks
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8 weeks
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Changes in Fasting Insulin Level
Tijdsspanne: 8 weeks
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8 weeks
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Changes in Prostate Tissue Metabolomic Profile
Tijdsspanne: 8 weeks
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8 weeks
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Changes in Prostate Tissue DNA Methylation
Tijdsspanne: 8 weeks
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8 weeks
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Adeel Kaiser, MD, Assistant Professor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HP-00072961
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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