Can a longer overnight fast help men on prostate cancer treatment?
NCT ID NCT07462403
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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40 people
The number who actually took part.
- Started
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May 2024
- Finished
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May 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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Other studies related to the condition(s) this trial covers.
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