Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

NCT ID: NCT06172283

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2028-12-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intermittent Fasting

Intervention Type: OTHER

Dietary intervention

Interventions

Intermittent Fasting

Dietary intervention

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Roberto Pili

Associate Dean for Cancer Research and Integrative Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University at Buffalo/Great Lakes Cancer Center

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Roberto Pili, MD

Role: CONTACT

rpili@buffalo.edu

716-881-8918

Kyle Pasquariello

Role: CONTACT

KPasquariello@gppconline.com

716-529-6470

Facility Contacts

Roberto Pili

Role: primary

rpili@buffalo.edu

716-881-8918

Other Identifiers

STUDY00007635

Identifier Type: -

Identifier Source: org_study_id