Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy

NCT07463092 | Recruiting

• 1 other identifier: 89367125.1.3001.0068
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Sarcopenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks.

Secondary Outcomes (2)

• Muscle strength

  Baseline and 12 weeks.

• Muscle mass

  Baseline and 12 weeks.

Study Arms (2)

Creatine Supplementation + Resistance Training

EXPERIMENTAL

Participants assigned to the experimental arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of creatine monohydrate. Creatine supplementation will be administered daily throughout the intervention period.

Dietary Supplement: Creatine Monohydrate; Behavioral: Resistance training

Placebo (Maltodextrin) + Resistance Training

ACTIVE COMPARATOR

Participants assigned to the control arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of maltodextrin. Maltodextrin will be administered daily throughout the intervention period.

Dietary Supplement: Maltodextrin; Behavioral: Resistance training

Interventions

Maltodextrin DIETARY_SUPPLEMENT

Participants will receive 5 g/day of maltodextrin, matched in appearance and caloric content to creatine, throughout the 12-week supervised resistance training program.

Placebo (Maltodextrin) + Resistance Training

Resistance training BEHAVIORAL

Participants 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.

Also known as: Strength training, Supervised resistance training, Progressive resistance training

Creatine Supplementation + Resistance Training; Placebo (Maltodextrin) + Resistance Training

Creatine Monohydrate DIETARY_SUPPLEMENT

Participants will receive 5 g/day of creatine monohydrate throughout the 12-week supervised resistance training program.

Creatine Supplementation + Resistance Training

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• InCor Heart Institute: collaborator
• Instituto do Cancer do Estado de São Paulo: collaborator
• Medical school of the University of São Paulo (FMUSP): collaborator

Study Sites (1)

School of Physical Education and Sport - USP

São Paulo, São Paulo, 05508-030, Brazil

RECRUITING

Related Publications (3)

• Yuan F, Wang Y, Xiao X, Zhang X, Jing M, Kamecki H, Tan YG, Barreras SG, Aragon-Ching JB, Ma Z, Zhang P, Chang D, You Y. A systematic review evaluating the effectiveness of exercise training on physical condition in prostate cancer patients undergoing androgen deprivation therapy. Transl Androl Urol. 2023 Aug 31;12(8):1336-1350. doi: 10.21037/tau-23-272. Epub 2023 Aug 4.

  PMID: 37680229 RESULT

• McTiernan A, Friedenreich CM, Katzmarzyk PT, Powell KE, Macko R, Buchner D, Pescatello LS, Bloodgood B, Tennant B, Vaux-Bjerke A, George SM, Troiano RP, Piercy KL; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity in Cancer Prevention and Survival: A Systematic Review. Med Sci Sports Exerc. 2019 Jun;51(6):1252-1261. doi: 10.1249/MSS.0000000000001937.

  PMID: 31095082 RESULT

• Kovac MB, Pavlin T, Cavka L, Ribnikar D, Spazzapan S, Templeton AJ, Seruga B. The trajectory of sarcopenia following diagnosis of prostate cancer: A systematic review and meta-analysis. J Geriatr Oncol. 2023 Sep;14(7):101594. doi: 10.1016/j.jgo.2023.101594. Epub 2023 Jul 22.

  PMID: 37482497 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Sarcopenia

Interventions

Creatine; maltodextrin; Resistance Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guilherme WP da Fonseca, PhD

  School of Physical Education and Sport - USP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme WP da Fonseca, PhD

CONTACT

+55 11 3091 2137; guilhermefonseca@usp.br

Comitê de Ética em Pesquisa da EEFE-USP

CONTACT

+55 11 3091 3097; cep39@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and investigators are blinded to group assignment, managed by an external researcher. The supplements are identical in appearance, taste, and caloric content.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-group parallel assignment comparing creatine supplementation with resistance training versus placebo with resistance training for 12 weeks.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)