Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

NCT06172283 | Recruiting DMC

• 1 other identifier: STUDY00007635
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  3 years

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

  3 years

Study Arms (1)

Intermittent Fasting

EXPERIMENTAL

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

Interventions

Intermittent Fasting OTHER

Dietary intervention

Intermittent Fasting

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo/Great Lakes Cancer Center

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Roberto Pili, MD

CONTACT

716-881-8918; rpili@buffalo.edu

Kyle Pasquariello

CONTACT

716-529-6470; KPasquariello@gppconline.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Cancer Research and Integrative Oncology

Model Details: Longitudinal

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)