Creatine plus resistance training may help prostate cancer patients preserve muscle
NCT ID NCT06112990
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether taking creatine supplements along with a home-based resistance training program can help men with metastatic prostate cancer maintain muscle mass and reduce fatigue. Two hundred participants will be randomly assigned to receive either creatine or a placebo, plus supervised exercise twice a week for 52 weeks. The goal is to improve physical function and quality of life during hormone therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- creatine monohydrate (a dietary supplement)
- What this could lead to
- If it works, this could offer a safe, non-drug way to help men with advanced prostate cancer maintain muscle, reduce fatigue, and improve quality of life during hormone therapy.
- What could go wrong
- This is a phase 3 trial but still experimental. The supplement may not provide significant benefit over exercise alone, and results may not apply to all patients. No serious risks are expected, but individual responses vary.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- 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.
Show the full entry requirements Hide 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: * Subject age ≥ 18 years old. * Metastatic castration-sensitive prostate cancer patients who have not met criteria for disease progression (per Prostate Cancer Working Group guidelines) on current systemic therapy * Currently treated with surgical castration or medical castration with Gonadotropin-releasing hormone (GnRH) agonists/antagonists, and/or an androgen receptor pathway inhibitor (ARPI)) aka novel hormone therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). Must have started the current regimen at least 12 weeks prior to enrollment. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 * Not currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training (e.g., time set aside in your day to workout) ≥ two days per week. * Regular access to an electronic device with internet service and ability for video calls (e.g., computer, smart phone, iPad, tablet, etc). * Access to an active MyChart account or the willingness to create an account for the purposes of the trial. * Willingness to engage in a home-based resistance exercise program two days per week. * Willingness to take creatine monohydrate supplementation or placebo for the duration of the 52 week trial and to avoid taking additional creatine-containing supplementation or other nutritional supplementation during the study period. * Willingness to complete and submit weekly supplementation logs to study personnel throughout the duration of the 52-week study via email, text, in person, or verbally verified over the phone. * Willingness to complete three in-person assessment sessions (baseline, 24-, and 52-weeks). * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment. * Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2. * ECOG Performance Status ≥ 3
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Huntsman Cancer Institute
RECRUITINGSalt Lake City, Utah, 84112, United States
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Other studies related to the condition(s) this trial covers.
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- Two-Drug combo targets prostate cancer that outsmarts hormone therapy
- AI chatbot may calm nerves after a prostate cancer diagnosis
- Can a common diabetes drug slow prostate cancer progression?
- Chemo combo vs. radioactive drug: which tames aggressive prostate cancer?
- Can a blood filtering technique reveal more about prostate cancer spread?