Prostate CancerNCT07463092
Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy
A study testing Creatine Monohydrate, Maltodextrin and Resistance training in people with Prostate Cancer and Sarcopenia, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer, Sarcopenia
- What is being tested?
- Creatine Monohydrate, Maltodextrin and Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
School of Physical Education and Sport - USP
São Paulo, São Paulo, 05508-030
Guilherme WP da Fonseca, PhD, +55 11 3091 2137, guilhermefonseca@usp.br
Comitê de Ética em Pesquisa da EEFE-USP, +55 11 3091 3097, cep39@usp.br
About this study
Official title: The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy
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.
Read the detailed description
Men receiving androgen-deprivation therapy (ADT) for prostate cancer often experience significant loss of muscle mass, reduction in muscle strength, and increased fat mass. These changes can lead to sarcopenia, poorer physical function, and lower quality of life. Resistance training is known to improve muscle mass and strength in this population, but it is not clear whether adding creatine supplementation can further enhance these benefits. This study will investigate whether combining creatine monohydrate supplementation with a 12-week supervised resistance training program leads to greater improvements in muscle health compared to resistance training alone. Creatine is a nutritional supplement that may help increase muscle energy availability and support muscle growth and function, but its effects in men undergoing ADT have not been fully established. Participants will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) once daily throughout the 12-week resistance training program. All patients will follow the same structured resistance exercise protocol, supervised by trained professionals. The study will evaluate changes in muscle mass, muscle strength, physical performance, muscle density measured by ultrasound, inflammatory markers, vascular function, and other indicators of muscle health. The goal of this study is to determine whether creatine supplementation is a safe and effective strategy to improve muscle quality, physical function, and overall health for men receiving ADT. Findings from this trial may help guide future recommendations for exercise and nutritional support in this population.
- Conditions
- Prostate Cancer, Sarcopenia
- Being tested
- Creatine Monohydrate, Maltodextrin, Resistance training
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy, Creatine, Resistance Training, Muscle Density, Sarcopenia
- Medical subject headings
- Prostatic Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohydrateDietary supplement
Participants will receive 5 g/day of creatine monohydrate throughout the 12-week supervised resistance training program.
MaltodextrinDietary 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.
Resistance trainingBehavioural
Also called Strength training, Supervised resistance training, Progressive resistance training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Maltodextrin; Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks.
Secondary outcomes (2)
Muscle strength
Muscle strength will be assessed using a handgrip dynamometer. The higher value of three attempts will be used.
Measured: Baseline and 12 weeks.
Muscle mass
Muscle mass will be assessed using Dual-energy X-ray absorptiometry (DXA).
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 May 2026
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-group parallel assignment comparing creatine supplementation with resistance training versus placebo with resistance training for 12 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, Instituto do Cancer do Estado de São Paulo
- Responsible party
- Principal investigator, Guilherme Wesley Peixoto da Fonseca, University of Sao Paulo
- Investigators
- Guilherme WP da Fonseca, PhD, Principal investigator, School of Physical Education and Sport - USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463092
- Sponsor's protocol ID
- 89367125.1.3001.0068
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Decision has not been made yet
Publications
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.
PubMed 37680229McTiernan 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.
PubMed 31095082Kovac 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.
PubMed 37482497
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT07463092
- Acronym / sponsor ID
- 89367125.1.3001.0068
- Conditions
- Prostate Cancer, Sarcopenia
- Keywords
- Prostate Cancer, Androgen Deprivation Therapy, Creatine, Resistance Training, Muscle Density, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Instituto do Cancer do Estado de São Paulo
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Men receiving androgen-deprivation therapy (ADT) for prostate cancer often experience significant loss of muscle mass, reduction in muscle strength, and increased fat mass. These changes can lead to sarcopenia, poorer physical function, and lower quality of life. Resistance training is known to improve muscle mass and strength in this population, but it is not clear whether adding creatine supplementation can further enhance these benefits. This study will investigate whether combining creatine monohydrate supplementation with a 12-week supervised resistance training program leads to greater improvements in muscle health compared to resistance training alone. Creatine is a nutritional supplement that may help increase muscle energy availability and support muscle growth and function, but its effects in men undergoing ADT have not been fully established. Participants will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) once daily throughout the 12-week resistance training program. All patients will follow the same structured resistance exercise protocol, supervised by trained professionals. The study will evaluate changes in muscle mass, muscle strength, physical performance, muscle density measured by ultrasound, inflammatory markers, vascular function, and other indicators of muscle health. The goal of this study is to determine whether creatine supplementation is a safe and effective strategy to improve muscle quality, physical function, and overall health for men receiving ADT. Findings from this trial may help guide future recommendations for exercise and nutritional support in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group parallel assignment comparing creatine supplementation with resistance training versus placebo with resistance training for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Creatine Supplementation + Resistance Training | Experimental | Dietary Supplement: Creatine Monohydrate, Behavioral: Resistance trainingParticipants 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. |
| Placebo (Maltodextrin) + Resistance Training | Active comparator | Dietary Supplement: Maltodextrin, Behavioral: Resistance trainingParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine MonohydrateParticipants will receive 5 g/day of creatine monohydrate throughout the 12-week supervised resistance training program. | Dietary supplement | Creatine Supplementation + Resistance Training |
| MaltodextrinParticipants will receive 5 g/day of maltodextrin, matched in appearance and caloric content to creatine, throughout the 12-week supervised resistance training program. | Dietary supplement | Placebo (Maltodextrin) + Resistance Training |
| Resistance trainingAlso: Strength training, Supervised resistance training, Progressive resistance trainingParticipants 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. | Behavioural | Creatine Supplementation + Resistance Training, Placebo (Maltodextrin) + Resistance Training |
Primary outcome
Muscle Density (Ultrasound-derived Echo Intensity and Thickness)
Time frame: Baseline and 12 weeks.
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.
2 secondary outcomes
Muscle strength
Time frame: Baseline and 12 weeks.
Muscle mass
Time frame: Baseline and 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 37680229Yuan 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.
- Results publication: PubMed 31095082McTiernan 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.
- Results publication: PubMed 37482497Kovac 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.
- Individual participant dataSharing planned: No. Decision has not been made yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guilherme WP da Fonseca, PhD principal investigator
School of Physical Education and Sport - USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohydrate, Maltodextrin and Resistance training in people with Prostate Cancer and Sarcopenia, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guilherme WP da Fonseca, PhD (+55 11 3091 2137, guilhermefonseca@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Density (Ultrasound-derived Echo Intensity and Thickness) (time frame: Baseline and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07463092, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.