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NCT Number: NCT06172283

Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo/Great Lakes Cancer Center

Buffalo, New York, 14203, United States

Location status: Recruiting

Location contact

Roberto Pili

CONTACT

[email protected]

716-881-8918

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intermittent fasting

Other

Dietary intervention

Primary outcomes

  1. Enrollment rate

    Time frame: 3 years

    Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy

  2. Drop-out rate

    Time frame: 3 years

    Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy

Secondary outcomes

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

    Time frame: 3 years

    Clinical efficacy of the combination of intermittent fasting with or without a plant-enriched diet plus androgen deprivation therapy

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

    Time frame: 3 years

    Safety, tolerability and reduction of common toxicities of the combination of intermittent fasting and the option of a plant-enriched diet intervention as compared to historical data.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyle Pasquariello

CONTACT

[email protected]

716-529-6470

Roberto Pili, MD

CONTACT

[email protected]

716-881-8918

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Dec 15, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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