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Can a longer overnight fast help men on prostate cancer treatment?

NCT ID NCT07462403

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small pilot study tested a 3-month program where men with prostate cancer on hormone therapy were encouraged to fast for 12 to 16 hours each night, supported by weekly coaching calls and text messages. The 40 participants found the program feasible and satisfying, with some showing weight loss and improved quality of life. However, the results were not strong enough to prove the program works, so larger studies are needed.

What this could mean

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

Active substance
prolonged nightly fasting plus telehealth coaching
What this could lead to
If it works, this could offer a simple lifestyle approach to help men on hormone therapy manage weight and improve quality of life.
What could go wrong
This was a small pilot study with only 40 participants, and the improvements seen were not statistically significant. Larger trials are needed to confirm any real benefit.

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

40 people

The number who actually took part.

Started

May 2024

Finished

May 2025

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: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: * Must be 18 years of age or older * Provide signed and dated informed consent form * Had a histological diagnosis of PCa (Stage IIA-IVB) * Are beginning or receiving ADT (including medical castration with LHRH-agonist-antagonist androgen receptor modulators) for PCa with an anticipated duration of ≥ 3 months. The ADT is defined as: (a) Gonadotropin Releasing Hormone (GNRH) agonist (including leuprolide \[Lupron/Eligard\], goserelin \[Zoladex\], triptorelin \[Trelstar\], histrelin \[Vantas\], and abiraterone \[Zytiga\]) alone; (b) GNRH agonist with oral androgen receptor blockade (including bicalutamide \[Casodex\], flutamide \[Eulexin\], and enzalutamide \[Xtandi\]), and (c) GNRH agonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors. Patients on androgen receptor modulators and second-generation androgen receptor antagonists will qualify. * Intermittent ADT will be allowed as long as the overall duration is more than 3 months. * BMI ≥25 kg/m2 * Radiation therapy will be allowed concurrently. * Willing and able to comply with the protocol for the duration of the study * Able to speak, read and write English * Has a mobile phone with TXT capability. Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Inability to tolerate a normal diet (may include an active malabsorption syndrome at time of consent (i.e. Crohn's disease, major bowel resection leading to permanent malabsorption) * Patients on concurrent chemotherapy will be excluded. * ECOG score \> 2 * Medications such as finasteride/dutasteride/saw palmetto are not allowed. * Insulin injection or glyburide medication

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

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