RECRUITING

Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot, Feasibility Study of Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Quick Facts

Study Start:2023-12-05

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06172283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Roberto Pili, MD

CONTACT

716-881-8918

rpili@buffalo.edu

Kyle Pasquariello

CONTACT

716-529-6470

KPasquariello@gppconline.com

Study Locations (Sites)

University at Buffalo/Great Lakes Cancer Center

Buffalo, New York, 14203

United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-12-05

Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer