Creatine plus resistance training to improve muscle loss after androgen-deprivation therapy for prostate cancer

The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy

This trial will test whether daily creatine plus supervised resistance training for 12 weeks helps men on androgen-deprivation therapy for prostate cancer keep or restore muscle mass, strength, and physical function compared with training plus placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 40 Years and up
• Sex: Male
• Sponsor: University of Sao Paulo (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07463092 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial will enroll men on androgen-deprivation therapy and assign them to daily creatine monohydrate or a matched placebo while all participants complete a 12-week supervised resistance training program. Outcomes measured before and after the intervention include muscle density and architecture by ultrasound, body composition, muscle strength, functional performance tests, inflammatory biomarkers, and vascular function. The creatine and placebo are given once daily and exercise sessions occur three times per week under professional supervision. The study aims to determine whether adding creatine produces greater improvements in muscle health than resistance training alone.

Who should consider this trial

Good fit: Men aged 40 or older with localized prostate cancer who have been on continuous or intermittent androgen-deprivation therapy for at least six months, have ECOG ≤2, are not currently doing resistance training or taking creatine, and can attend thrice-weekly supervised sessions are ideal candidates.

Not a fit: Patients with dialysis-dependent renal failure, insulin-dependent diabetes, recent creatine use, those already engaged in regular resistance training, or those unable to complete supervised exercise are unlikely to benefit or qualify.

Why it matters

Potential benefit: If successful, this approach could help men on ADT preserve or increase muscle mass and strength and improve physical function during treatment.

How similar studies have performed: Resistance training has documented benefits for muscle mass and function in men on ADT and creatine has improved muscle outcomes in older adults, but combined creatine plus exercise specifically in the ADT population remains limited in direct evidence.

Eligibility criteria

Inclusion Criteria:

* 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 an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
* Not engaged in resistance training in the three months prior to the intervention;
* Not using creatine supplementation in the three months prior to the intervention;
* Willing to participate in a 12-week intervention consisting of resistance training performed three times per week and daily supplementation with creatine monohydrate or maltodextrin.

Exclusion Criteria:

* 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;
* Any hormonal treatment outside that established by the medical team;
* Patients planning to undergo chemotherapy within the next six months.

Where this trial is running

São Paulo, São Paulo

• School of Physical Education and Sport - USP — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Guilherme WP da Fonseca, PhD — School of Physical Education and Sport - USP
• Study coordinator: Guilherme WP da Fonseca, PhD

Conditions Prostate Cancer; Sarcopenia; Androgen Deprivation Therapy; Creatine; Resistance Training; Muscle Density