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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Utah

About this trial

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

Qualifiers

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

Disqualifiers

Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.

Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2.

ECOG Performance Status ≥ 3

Trial design

Treatments tested in this trial

  • creatine monohydrate
  • Placebo
  • Home-based, telehealth

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Utah

Lead sponsor

National Cancer Institute (NCI)

Collaborator