NCT06112990RecruitingPhase 3
Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression
Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to test the use of creatine monohydrate supplementation with resistance training to preserve muscle mass and help lessen prostate cancer progression. The main question it aims to answer is if this treatment will help maintain muscle mass to help in reducing fatigue and improving physical function, independence, and quality of life. Participants will be asked to participate in a 52-week exercise intervention consisting of a twice weekly telehealth resistance training program.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 18 Oct 2023
- Start date
- 9 Nov 2023
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- University of Utah
- Diseases
- Prostate cancer
- NCT number
- NCT06112990
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- From 9 Nov 2023 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
Lab values
- Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2.
Other
- ECOG Performance Status ≥ 3
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.