Clinical trial · Observational
Ketogenic Diet and Prostate Cancer Surveillance Pilot
A Ketogenic Diet Pilot Study for Overweight Prostate Cancer Patients on Active Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Weight loss
- timeFrame
- 8 weeks
Secondary outcomes (14)
- measure
- Changes in Testosterone Level
- timeFrame
- 8 weeks
- measure
- Changes in Estrogen Level
- timeFrame
- 8 weeks
- measure
- Changes in TNF-Alpha Level
- timeFrame
- 8 weeks
- measure
- Changes in C-Reactive Protein Level
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available