Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Last updated: February 13, 2025
Sponsor: State University of New York at Buffalo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

Intermittent Fasting

Clinical Study ID

NCT06172283
STUDY00007635
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 deprivationtherapy.

  • 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 baselinebiopsy prior to treatment.

  • Subjects must have a life expectancy of at least 6 months.

Exclusion

Exclusion Criteria:

  • Has an ECOG performance of 2 or higher.

  • Is currently participating and receiving study therapy or has participated in astudy of an investigational agent and received study therapy or used aninvestigational 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 laboratoryabnormality that might confound the results of the trial, interfere with thesubject's participation for the full duration of the trial, or is not in the bestinterest of the subject to participate, in the opinion of the treating investigator.

  • Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial.

  • Has a known allergy, intolerance, or medical contraindication to receiving thecontrast dye required for the protocol-specified CT/MRI imaging

  • Has any other medical intervention or condition which, in the opinion of thePrincipal Investigator, could compromise adherence with study requirements orotherwise compromise the study's objectives.

  • Is not willing and able to provide written informed consent for the trial.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Intermittent Fasting
Phase:
Study Start date:
December 05, 2023
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • University at Buffalo/Great Lakes Cancer Center

    Buffalo, New York 14203
    United States

    Active - Recruiting

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