Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Clinicaltrials.gov ID: NCT06172283
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 30

Conditions

Prostate Cancer

Summary

This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Eligibility Criteria

Inclusion Criteria:

* In order to be eligible for participation in this trial, the subject must:
* Be willing and able to provide written informed consent for the trial.
* Be male at birth and least 18 years of age on day of signing informed consent.
* Have measurable prostate cancer disease and be eligible for androgen deprivation therapy.
* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Demonstrate adequate organ function (all screening labs should be performed within 10 days of treatment initiation).
* Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment.
* Subjects must have a life expectancy of at least 6 months.

Exclusion Criteria:

* Has an ECOG performance of 2 or higher.
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the beginning of the treatment.
* Has a known additional malignancy that is progressing or requires active treatment.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Has a known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging
* Has any other medical intervention or condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.
* Is not willing and able to provide written informed consent for the trial.

Study Plan

Intermittent Fasting

EXPERIMENTAL

Patients will undergo 16h periods of fasting everyday. Optionally, patients will be offered to undergo a plant-based diet consisting of 20% plant based protein, 50% carbohydrates, and 30% fat for the duration of the study.

  • OTHER:

    Intermittent Fasting

    Description:

    Dietary intervention

Outcome Measures

Primary Outcome Measures

Enrollment rate

Time Frame: 3 years

Drop-out rate

Time Frame: 3 years

Secondary Outcome Measures

Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.

Time Frame: 3 years

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Time Frame: 3 years

Timeline

  • Last Updated
    December 15, 2023
  • Start Date
    December 15, 2023
  • Today
    January 23, 2025
  • Completion Date ( Estimated )
    December 31, 2028

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