Recruiting

Intermittent Caloric Restriction

Sponsor:

State University of New York at Buffalo

Code:

NCT06172283

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intermittent Fasting

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT06172283

Start date

Dec 5, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intermittent Fasting

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.

Interventions

Intermittent Fasting

Dietary intervention

Primary outcome measure

  • Enrollment rate [ Time Frame: 3 years ]
  • Drop-out rate [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Roberto Pili, MD

716-881-8918rpili@buffalo.edu

Kyle Pasquariello

716-529-6470KPasquariello@gppconline.com

Locations

University at Buffalo/Great Lakes Cancer Center

Recruiting

Buffalo, New York, United States, 14203

Contacts

Roberto Pili

716-881-8918rpili@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-04-22.