Intermittent fasting for prostate cancer patients on hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the feasibility of intermittent caloric restriction, potentially combined with a plant-enriched diet, in men with prostate cancer undergoing androgen deprivation therapy. The study will measure enrollment and drop-out rates, as well as compliance with the dietary regimen through self-reports. The aim is to determine whether this dietary approach can be effectively implemented in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• University at Buffalo/Great Lakes Cancer Center
  Buffalo, New York, United States Recruiting

Study contacts

• Study coordinator: Roberto Pili, MD
• Email: rpili@buffalo.edu
• Phone: 716-881-8918

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.