Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

A Pilot, Feasibility Study of 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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Intermittent Fasting

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Pili, MD; Phone Number: 716-881-8918; Email: rpili@buffalo.edu
• Study Contact Backup: Name: Kyle Pasquariello; Phone Number: 716-529-6470; Email: KPasquariello@gppconline.com

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo/Great Lakes Cancer Center
      • Contact: Roberto Pili; Phone Number: 716-881-8918; Email: rpili@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Intermittent Fasting; Dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy	3 years
Drop-out rate	Feasibility of intermittent fasting (with the option of a plant-enriched diet) in prostate cancer patients receiving androgen deprivation therapy	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.	Clinical efficacy of the combination of intermittent fasting with or without a plant-enriched diet plus androgen deprivation therapy	3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.	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.	3 years

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STUDY00007635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No