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Could fasting help prostate cancer treatment? small study aims to find out

NCT ID NCT06172283

Symptom relief Sponsor: State University of New York at Buffalo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study is testing whether intermittent fasting (with an optional plant-rich diet) is practical and helpful for 30 men with prostate cancer who are receiving hormone therapy (androgen deprivation therapy). The main goal is to see if patients can stick with the diet, not yet to prove it works. Researchers will also look for early signs of tumor response and any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intermittent fasting (caloric restriction with optional plant-enriched diet)
What this could lead to
If this approach works, it could point toward a way to improve treatment outcomes and reduce side effects for prostate cancer patients on hormone therapy.
What could go wrong
This is a very small, early pilot study with only 30 participants, focused on feasibility rather than proof of benefit. The diet may be hard to stick with, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University at Buffalo/Great Lakes Cancer Center

    RECRUITING

    Buffalo, New York, 14203, United States

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