NCT07463092 Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy
| NCT ID | NCT07463092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2028-12 |
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.
This trial targets 34 participants in total. It began in 2026-05-01 with a primary completion date of 2028-12.
⚠ 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
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.
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.
Contact & Investigator
Guilherme WP da Fonseca, PhD
PRINCIPAL INVESTIGATOR
School of Physical Education and Sport - USP
Frequently Asked Questions
Who can join the NCT07463092 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07463092 currently recruiting?
Yes, NCT07463092 is actively recruiting participants. Contact the research team at guilhermefonseca@usp.br for enrollment information.
Where is the NCT07463092 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07463092 clinical trial?
NCT07463092 is sponsored by University of Sao Paulo. The principal investigator is Guilherme WP da Fonseca, PhD at School of Physical Education and Sport - USP. The trial plans to enroll 34 participants.
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