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Creatine and Resistance Training for Metastatic Prostate Cancer

This study is testing if taking creatine monohydrate supplements along with a home-based resistance training program can help men with metastatic prostate cancer keep their muscle mass. The goal is to see if this combination can reduce fatigue, improve physical function, and enhance quality of life. You may be eligible if you are a man aged 18 or older with metastatic castration-sensitive prostate cancer who has not had their cancer worsen on current treatment. The study will measure changes in total lean muscle mass over 52 weeks to see if the treatment is successful. The current recruitment status is unclear.

Study design
This is a randomized controlled trial involving 200 participants. It is double-blind, meaning neither you nor the study team will know if you are receiving creatine or a placebo.
What's involved
You would participate in a 52-week exercise program, which includes twice-weekly telehealth resistance training sessions. You will also have assessments at the beginning, middle, and end of the 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 52 weeks, which is the end of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06112990

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression

Recruiting
PHASE3Ages 18+InterventionalTreatment
University of Utah
~200 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:creatine monohydratePlaceboHome-based, telehealth

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in total lean mass (kg) as measured by whole-body dual energy x-ray absorptiometry (DXA) scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm
Measured over 52 weeks

Conditions

Metastatic Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Adriana Coletta, PhD, MS, RD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Susan Sharry
[email protected]
801-585-3453
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2.
ECOG Performance Status ≥ 3

What this trial measures

  • Change in total lean mass (kg) as measured by whole-body dual energy x-ray absorptiometry (DXA) scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm52 weeks

    To test the efficacy of 52-weeks of home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) or placebo (PLA), Cr+RT vs. PLA+RT, on changes in muscle mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).