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Ketogenic Diet and Prostate Cancer Surveillance Pilot

NCT03194516 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2021-04-05

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Surveillance

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Adeel Kaiser, MD · Assistant Professor

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2019-01-09
Completion
2019-11-13

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194516 on ClinicalTrials.gov