Ketogenic Diet and Prostate Cancer Surveillance Pilot

NCT03194516 | Completed DMC

• 1 other identifier: HP-00072961
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; ketogenic diet; overweight, obese

Outcome Measures

Primary Outcomes (1)

• Weight loss

  8 weeks

Secondary Outcomes (14)

• Changes in Testosterone Level

  8 weeks

• Changes in Estrogen Level

  8 weeks

• Changes in TNF-Alpha Level

  8 weeks

• Changes in C-Reactive Protein Level

  8 weeks

• Changes in PSA Level

  8 weeks

Interventions

Surveillance OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic, community care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland GCCC

Baltimore, Maryland, 21201, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Prostate biopsy

MeSH Terms

Conditions

Prostatic Neoplasms; Overweight; Obesity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adeel Kaiser, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: June 21, 2017
• Study Start: June 12, 2017
• Primary Completion: January 9, 2019
• Study Completion: November 13, 2019
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)