This randomized, double-blind, placebo-controlled clinical trial will investigate the effects of creatine supplementation combined with a 12-week supervised resistance training program on muscle mass, muscle strength, physical performance (e.g., parameters of sarcopenia), and muscle density in men with prostate cancer undergoing androgen deprivation therapy (ADT). ADT often causes loss of lean mass, reduced muscle strength, functional impairment, and increased fat mass. Eligible male patients will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) in a double-blind manner, in addition to participating in the resistance exercise program. Assessments will be performed at baseline and after the 12-week intervention period and will include:
* Muscle density and architecture assessed by ultrasound * Body composition (lean mass and fat mass) * Muscle strength * Physical performance (functional performance tests) * Inflammatory biomarkers * Vascular function parameters
The primary goal is to assess whether creatine supplementation combined with resistance training can safely improve muscle quality and quantity, strength, and physical function in these patients. If effective and safe, the intervention could help reduce muscle loss and improve quality of life in men undergoing ADT.
Men aged ≥ 40 years;
Patients with histologically or cytologically confirmed localized prostate cancer;
Patients who have undergone surgical castration or pharmacological castration with gonadotropin-releasing hormone (GnRH/LHRH) agonists or antagonists for at least six months prior to the start of the intervention;
Patients receiving continuous or intermittent androgen deprivation therapy;
Patients with insulin-dependent diabetes mellitus;
Patients with dialysis-dependent renal failure;
Patients with severe chronic liver disease;
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²;
Parallel
Creatine Monohydrate
Dietary supplementParticipants will receive 5 g/day of creatine monohydrate throughout the 12-week supervised resistance training program.
Maltodextrin
Dietary supplementParticipants will receive 5 g/day of maltodextrin, matched in appearance and caloric content to creatine, throughout the 12-week supervised resistance training program.
Resistance training
BehavioralParticipants will complete a 12-week supervised, progressive resistance training program designed to improve muscle strength and muscle mass. Training sessions will be conducted under professional supervision and will occur three times per week. The program will target major muscle groups of the upper and lower body using weight machines and free weights. All participants in both study arms will follow the same resistance training protocol.
Muscle Density (Ultrasound-derived Echo Intensity and Thickness)
Muscle density will be assessed using ultrasound-derived measurements, including muscle thickness and echo intensity of selected muscle groups. Higher muscle density reflects improved muscle quality.
Muscle strength
Muscle strength will be assessed using a handgrip dynamometer. The higher value of three attempts will be used.
Muscle mass
Muscle mass will be assessed using Dual-energy X-ray absorptiometry (DXA).
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University of Sao Paulo
Lead sponsor
InCor Heart Institute
Collaborator
Medical school of the University of São Paulo (FMUSP)
Collaborator
Instituto do Cancer do Estado de São Paulo
Collaborator
