Prostate CancerGCC 1717NCT03194516
Ketogenic Diet and Prostate Cancer Surveillance Pilot
An observational study of Prostate Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Surveillance
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 13 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic, community care clinic
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland GCCC
Baltimore, Maryland, 21201
About this study
Official title: A Ketogenic Diet Pilot Study for Overweight Prostate Cancer Patients on Active Surveillance
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- Surveillance
- Keywords
- prostate cancer, ketogenic diet, overweight, obese
- Medical subject headings
- Prostatic Neoplasms, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveillanceOther
The investigators propose an 8-week ketogenic diet intervention with pre-/post-intervention assessment of serum and tissue metabolic and inflammatory biomarkers, including metabolomics analysis, among a sample of 12 overweight or obese prostate cancer patients on active surveillance. There will be no randomization; all patients will receive the diet intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 8 weeks
Secondary outcomes (14)
Changes in Testosterone Level
Measured: 8 weeks
Changes in Estrogen Level
Measured: 8 weeks
Changes in TNF-Alpha Level
Measured: 8 weeks
Changes in C-Reactive Protein Level
Measured: 8 weeks
Changes in PSA Level
Measured: 8 weeks
Changes in High Density Lipoprotein (HDL)
Measured: 8 weeks
Changes in Low Density Lipoprotein (LDL)
Measured: 8 weeks
Changes in Triglyceride Level
Measured: 8 weeks
Changes in Total Cholesterol Level
Measured: 8 weeks
Changes in Fasting Glucose Level
Measured: 8 weeks
Changes in Leptin Level
Measured: 8 weeks
Changes in Fasting Insulin Level
Measured: 8 weeks
Changes in Prostate Tissue Metabolomic Profile
Measured: 8 weeks
Changes in Prostate Tissue DNA Methylation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start12 Jun 2017
- Primary completion9 Jan 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Adeel Kaiser, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194516
- Sponsor's protocol ID
- HP-00072961
- Acronym
- GCC 1717
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2017
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ketogenic Diet Pilot Study for Overweight Prostate Cancer Patients on Active Surveillance
- ClinicalTrials.gov ID
- NCT03194516
- Acronym / sponsor ID
- GCC 1717 / HP-00072961
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, ketogenic diet, overweight, obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, community care clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveillanceThe investigators propose an 8-week ketogenic diet intervention with pre-/post-intervention assessment of serum and tissue metabolic and inflammatory biomarkers, including metabolomics analysis, among a sample of 12 overweight or obese prostate cancer patients on active surveillance. There will be no randomization; all patients will receive the diet intervention. | Other | – |
Primary outcome
Weight loss
Time frame: 8 weeks
14 secondary outcomes
Changes in Testosterone Level
Time frame: 8 weeks
Changes in Estrogen Level
Time frame: 8 weeks
Changes in TNF-Alpha Level
Time frame: 8 weeks
Changes in C-Reactive Protein Level
Time frame: 8 weeks
Changes in PSA Level
Time frame: 8 weeks
Changes in High Density Lipoprotein (HDL)
Time frame: 8 weeks
Changes in Low Density Lipoprotein (LDL)
Time frame: 8 weeks
Changes in Triglyceride Level
Time frame: 8 weeks
Changes in Total Cholesterol Level
Time frame: 8 weeks
Changes in Fasting Glucose Level
Time frame: 8 weeks
Changes in Leptin Level
Time frame: 8 weeks
Changes in Fasting Insulin Level
Time frame: 8 weeks
Changes in Prostate Tissue Metabolomic Profile
Time frame: 8 weeks
Changes in Prostate Tissue DNA Methylation
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeel Kaiser, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.