Using creatine and resistance training to help maintain muscle mass in prostate cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of creatine monohydrate supplementation combined with a telehealth resistance training program over 52 weeks for patients with metastatic castration-sensitive prostate cancer. The study aims to determine if this intervention can preserve muscle mass, reduce fatigue, and improve overall physical function and quality of life. Participants will be randomly assigned to receive either the creatine supplementation with resistance training or a placebo with resistance training, with evaluations conducted at baseline, mid-point, and after 52 weeks. The trial will also assess markers of cancer progression throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Huntsman Cancer Institute
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Adriana Coletta, PhD, MS, RD — Huntsman Cancer Institute
• Study coordinator: Susan Sharry
• Email: susan.sharry@hci.utah.edu
• Phone: 801-585-3453

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.