NCT06112990 Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression
| NCT ID | NCT06112990 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Utah |
| Condition | Metastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-09 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2023-11-09 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Adriana Coletta, PhD, MS, RD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute
Frequently Asked Questions
Who can join the NCT06112990 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06112990 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT06112990 currently recruiting?
Yes, NCT06112990 is actively recruiting participants. Contact the research team at susan.sharry@hci.utah.edu for enrollment information.
Where is the NCT06112990 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06112990 clinical trial?
NCT06112990 is sponsored by University of Utah. The principal investigator is Adriana Coletta, PhD, MS, RD at Huntsman Cancer Institute. The trial plans to enroll 200 participants.
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