Ignite Creation Date:
2024-05-06 @ 10:11 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03194516
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2017-04-21
Brief Title:
Ketogenic Diet and Prostate Cancer Surveillance Pilot
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Ketogenic Diet Pilot Study for Overweight Prostate Cancer Patients on Active Surveillance
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GCC 1717
Brief Summary:
Men with indolent forms of prostate cancer are managed expectantly using active surveillance with a goal of delaying treatment and its deleterious side effects However almost 50 of men experience progression with this approach and require treatment Elevated body mass index BMI is associated with a dramatically increased risk of progression to higher grade prostate cancer The goal of the proposed research is to gather preliminary data evaluating the effects of a promising dietary strategy to delay cancer progression in overweight and obese prostate cancer patients undergoing active surveillance The investigators hypothesize that a ketogenic diet intervention may reduce BMI and favorably alter the prostate microenvironment
Detailed Description:
More than 16 million new cases of cancer are estimated in the United States in 2016 with almost 600000 individuals dying from the disease Prostate cancer alone is responsible for 180000 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 kgm2 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
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 kgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None