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RECRUITINGNA

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

NCT06172283•State University of New York at Buffalo

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.

Locations (1)

University at Buffalo/Great Lakes Cancer Center

Buffalo, New York, United States

Key Dates

Start Date

December 5, 2023

Primary Completion Date

January 1, 2027

Completion Date

December 31, 2028

Last Updated

February 17, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Intermittent Fasting

OTHER

Contacts

Roberto Pili, MD

CONTACT

716-881-8918 rpili@buffalo.edu

Kyle Pasquariello

CONTACT

716-529-6470 KPasquariello@gppconline.com

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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