Recruiting
Phase 3

Creatine & Resistance Training

Sponsor:

University of Utah

Code:

NCT06112990

Conditions

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

creatine monohydrate

Placebo

Home-based, telehealth

Study Details

Brief summary:

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.

Conditions

Metastatic Prostate Cancer

Study ID

NCT06112990

Start date

Nov 9, 2023

Status verified date

Jun, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr)

placebo comparator: Arm 2

Home-based, telehealth resistance training (RT) with placebo (PLA)

Interventions

creatine monohydrate

Creatine is part of the phosphagen system and plays a critical role in energy metabolism. Creatine monohydrate supplementation increases availability of creatine and phosphocreatine in the skeletal muscle. Increased phosphocreatine enables greater buffering of adenosine triphosphate, an organic compound providing energy to cells, enhancing training volume (e.g., an individual can work-out harder and longer).This augmentation in exercise capacity amplifies training adaptations. Additionally, creatine monohydrate supplementation reduces levels of inflammatory markers, which are associated with severe muscle loss.

Placebo

Placebo supplementation consists of a flavorless, colorless, dextrose powder and will be supplied in concealed, unlabeled packaging.

Home-based, telehealth

Home-based, individualized, whole-body RT program, supervised via the telehealth platform within the electronic medical record system. The RT program consists of 12 resistance exercises, focusing on all major muscle groups including upper and lower body, core, and whole-body. Exercises within each participant's individualized RT program progress with a periodization model as recommended by the American College of Sports Medicine. In addition, the cancer exercise trainer will inquire about space availability in the home for completing resistance prior to developing the personalized prescription. This logistical information is key to ensure feasibility of completing the exercises prescribed. Participants will be provided with beginner and advanced sets of elastic resistance bands to enable progression throughout the 52-week study.

Primary outcome measure

  • 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 [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Susan Sharry

801-585-3453susan.sharry@hci.utah.edu

Locations

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Adriana Coletta, PHD, MS, RD

801-213-6012adriana.coletta@hci.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-06-03.