Metastatic Prostate CancerPhase 3CREATINE-52NCT06112990
Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression
A Phase 3 study testing creatine monohydrate and Home-based, telehealth in people with Metastatic Prostate Cancer, run by University of Utah at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the use of creatine monohydrate supplementation with resistance training to preserve muscle mass and help lessen prostate cancer progression. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- creatine monohydrate and Home-based, telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to 30 Nov 2028
- Phase
- Phase 3
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age ≥ 18 years old.
- Metastatic castration-sensitive prostate cancer patients who have not met criteria for disease progression (per Prostate Cancer Working Group guidelines) on current systemic therapy
- Currently treated with surgical castration or medical castration with Gonadotropin-releasing hormone (GnRH) agonists/antagonists, and/or an androgen receptor pathway inhibitor (ARPI)) aka novel hormone therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). Must have started the current regimen at least 12 weeks prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Not currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training (e.g., time set aside in your day to workout) ≥ two days per week.
- Regular access to an electronic device with internet service and ability for video calls (e.g., computer, smart phone, iPad, tablet, etc).
Show all 12Show fewer
- Access to an active MyChart account or the willingness to create an account for the purposes of the trial.
- Willingness to engage in a home-based resistance exercise program two days per week.
- Willingness to take creatine monohydrate supplementation or placebo for the duration of the 52 week trial and to avoid taking additional creatine-containing supplementation or other nutritional supplementation during the study period.
- Willingness to complete and submit weekly supplementation logs to study personnel throughout the duration of the 52-week study via email, text, in person, or verbally verified over the phone.
- Willingness to complete three in-person assessment sessions (baseline, 24-, and 52-weeks).
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
- Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2.
- ECOG Performance Status ≥ 3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Adriana Coletta, PHD, MS, RD, 801-213-6012, adriana.coletta@hci.utah.edu
About this study
Official title: Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial
The goal of this clinical trial is to test the use of creatine monohydrate supplementation with resistance training to preserve muscle mass and help lessen prostate cancer progression.
The main question it aims to answer is if this treatment will help maintain muscle mass to help in reducing fatigue and improving physical function, independence, and quality of life.
Participants will be asked to participate in a 52-week exercise intervention consisting of a twice weekly telehealth resistance training program.
Read the detailed description
This is a parallel, double-blind randomized controlled trial to test the effects of 52-weeks of creatine monohydrate supplementation with resistance training (Cr+RT) compared with placebo (PLA) and RT (PLA+RT) with our team's established, effective, home-based, telehealth RT program in 200 metastatic castration sensitive prostate cancer (mCSPC) survivors receiving androgen deprivation therapy (ADT). The study team will evaluate muscle mass, health outcomes (fatigue, physical function, independence, insulin sensitivity, quality of life), and markers or cancer progression (prostate specific antigen, cell-free DNA) at baseline, mid-point, and 52-weeks. RT will be carried out twice weekly with elastic resistance bands, and the study will utilize an established creatine monohydrate supplementation protocol for creatine and PLA delivery.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- creatine monohydrate, Placebo, Home-based, telehealth
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatine monohydrateDietary supplement
Also called Creatine
Creatine is part of the phosphagen system and plays a critical role in energy metabolism. Creatine monohydrate supplementation increases availability of creatine and phosphocreatine in the skeletal muscle. Increased phosphocreatine enables greater buffering of adenosine triphosphate, an organic compound providing energy to cells, enhancing training volume (e.g., an individual can work-out harder and longer).This augmentation in exercise capacity amplifies training adaptations. Additionally, creatine monohydrate supplementation reduces levels of inflammatory markers, which are associated with severe muscle loss.
PlaceboOther
Placebo supplementation consists of a flavorless, colorless, dextrose powder and will be supplied in concealed, unlabeled packaging.
Home-based, telehealthBehavioural
Home-based, individualized, whole-body RT program, supervised via the telehealth platform within the electronic medical record system. The RT program consists of 12 resistance exercises, focusing on all major muscle groups including upper and lower body, core, and whole-body. Exercises within each participant's individualized RT program progress with a periodization model as recommended by the American College of Sports Medicine. In addition, the cancer exercise trainer will inquire about space availability in the home for completing resistance prior to developing the personalized prescription. This logistical information is key to ensure feasibility of completing the exercises prescribed. Participants will be provided with beginner and advanced sets of elastic resistance bands to enable progression throughout the 52-week study.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) Receives: Dietary Supplement: creatine monohydrate; Behavioral: Home-based, telehealth |
| Arm 2 | Placebo comparator | Home-based, telehealth resistance training (RT) with placebo (PLA) Receives: Other: Placebo; Behavioral: Home-based, telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total lean mass (kg) as measured by whole-body dual energy x-ray absorptiometry (DXA) scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm
To test the efficacy of 52-weeks of home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) or placebo (PLA), Cr+RT vs. PLA+RT, on changes in muscle mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
Measured: 52 weeks
Secondary outcomes (8)
Change in fatigue score as measured by the FACIT-Fatigue questionnaire from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
To test the intervention's effect on fatigue in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
Measured: 52 weeks
Change in physical function scores as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
To test the intervention's effect on physical function in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
Measured: 52 weeks
Change in physical function scores as measured by the Short Physical Performance Battery test from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
To test the intervention's effect on physical function in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
Measured: 52 weeks
Change in handgrip strength (kg) as measured by hand dynamometer from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
To test the intervention's effect on strength in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
Measured: 52 weeks
Change in independence score as measured by the Katz Independence scale from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
To test the intervention's effect on independence in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
Measured: 52 weeks
Change in insulin sensitivity as measured by homeostasis model assessment (HOMA) for insulin resistance (IR) (HOMA-IR) from a blood draw from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
To test the intervention's effect on insulin sensitivity in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200) .
Measured: 52 weeks
Change in fat mass (kg) as measured by whole-body DXA scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
To test the intervention's effect on fat mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200) .
Measured: 52 weeks
Change in quality of life score as measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
To test the intervention's effect on quality of life in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200) .
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start9 Nov 2023
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, randomized, controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Adriana Coletta, PhD, MS, RD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112990
- Sponsor's protocol ID
- HCI168125
- Other IDs
- 1R01CA281759-01
- Acronym
- CREATINE-52
- Status last verified
- Jun 2026
- First submitted
- 18 Oct 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coletta AM, Simon LH, Maslana K, Taylor S, Larson K, Hansen PA, Thomas VM, Ulrich CM, Kohli M, Chipman J, Swami U, Gupta S, Maughan BL, Agarwal N. Creatine supplementation and resistance training to preserve muscle mass and attenuate cancer progression (CREATINE-52): a protocol for a double-blind randomized controlled trial. BMC Cancer. 2024 Apr 18;24(1):493. doi: 10.1186/s12885-024-12260-3.
PubMed 38637770
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06112990
- Acronym / sponsor ID
- CREATINE-52 / HCI168125
- Conditions
- Metastatic Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 2 Nov 2023 (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.
The goal of this clinical trial is to test the use of creatine monohydrate supplementation with resistance training to preserve muscle mass and help lessen prostate cancer progression.
The main question it aims to answer is if this treatment will help maintain muscle mass to help in reducing fatigue and improving physical function, independence, and quality of life.
Participants will be asked to participate in a 52-week exercise intervention consisting of a twice weekly telehealth resistance training program.
Detailed description
This is a parallel, double-blind randomized controlled trial to test the effects of 52-weeks of creatine monohydrate supplementation with resistance training (Cr+RT) compared with placebo (PLA) and RT (PLA+RT) with our team's established, effective, home-based, telehealth RT program in 200 metastatic castration sensitive prostate cancer (mCSPC) survivors receiving androgen deprivation therapy (ADT). The study team will evaluate muscle mass, health outcomes (fatigue, physical function, independence, insulin sensitivity, quality of life), and markers or cancer progression (prostate specific antigen, cell-free DNA) at baseline, mid-point, and 52-weeks. RT will be carried out twice weekly with elastic resistance bands, and the study will utilize an established creatine monohydrate supplementation protocol for creatine and PLA delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Dietary Supplement: creatine monohydrate, Behavioral: Home-based, telehealthHome-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) |
| Arm 2 | Placebo comparator | Other: Placebo, Behavioral: Home-based, telehealthHome-based, telehealth resistance training (RT) with placebo (PLA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject age ≥ 18 years old.
- Metastatic castration-sensitive prostate cancer patients who have not met criteria for disease progression (per Prostate Cancer Working Group guidelines) on current systemic therapy
- Currently treated with surgical castration or medical castration with Gonadotropin-releasing hormone (GnRH) agonists/antagonists, and/or an androgen receptor pathway inhibitor (ARPI)) aka novel hormone therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). Must have started the current regimen at least 12 weeks prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Not currently adhering to national physical activity guidelines for resistance training, as defined as participating in structured resistance training (e.g., time set aside in your day to workout) ≥ two days per week.
Key exclusion criteria (3 listed)
- Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
- Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2.
- ECOG Performance Status ≥ 3
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 monohydrateAlso: CreatineCreatine is part of the phosphagen system and plays a critical role in energy metabolism. Creatine monohydrate supplementation increases availability of creatine and phosphocreatine in the skeletal muscle. Increased phosphocreatine enables greater buffering of adenosine triphosphate, an organic compound providing energy to cells, enhancing training volume (e.g., an individual can work-out harder and longer).This augmentation in exercise capacity amplifies training adaptations. Additionally, creatine monohydrate supplementation reduces levels of inflammatory markers, which are associated with severe muscle loss. | Dietary supplement | Arm 1 |
| PlaceboPlacebo supplementation consists of a flavorless, colorless, dextrose powder and will be supplied in concealed, unlabeled packaging. | Other | Arm 2 |
| Home-based, telehealthHome-based, individualized, whole-body RT program, supervised via the telehealth platform within the electronic medical record system. The RT program consists of 12 resistance exercises, focusing on all major muscle groups including upper and lower body, core, and whole-body. Exercises within each participant's individualized RT program progress with a periodization model as recommended by the American College of Sports Medicine. In addition, the cancer exercise trainer will inquire about space availability in the home for completing resistance prior to developing the personalized prescription. This logistical information is key to ensure feasibility of completing the exercises prescribed. Participants will be provided with beginner and advanced sets of elastic resistance bands to enable progression throughout the 52-week study. | Behavioural | Arm 1, Arm 2 |
Primary outcome
Change in total lean mass (kg) as measured by whole-body dual energy x-ray absorptiometry (DXA) scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm
Time frame: 52 weeks
To test the efficacy of 52-weeks of home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr) or placebo (PLA), Cr+RT vs. PLA+RT, on changes in muscle mass in metastatic castration sensitive prostate cancer survivors receiving androgen deprivation therapy (n=200).
8 secondary outcomes
Change in fatigue score as measured by the FACIT-Fatigue questionnaire from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
Time frame: 52 weeks
Change in physical function scores as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
Time frame: 52 weeks
Change in physical function scores as measured by the Short Physical Performance Battery test from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
Time frame: 52 weeks
Change in handgrip strength (kg) as measured by hand dynamometer from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
Time frame: 52 weeks
Change in independence score as measured by the Katz Independence scale from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
Time frame: 52 weeks
Change in insulin sensitivity as measured by homeostasis model assessment (HOMA) for insulin resistance (IR) (HOMA-IR) from a blood draw from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
Time frame: 52 weeks
Change in fat mass (kg) as measured by whole-body DXA scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
Time frame: 52 weeks
Change in quality of life score as measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.
Time frame: 52 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 3 Jun 2026.
- Derived from this study: PubMed 38637770Coletta AM, Simon LH, Maslana K, Taylor S, Larson K, Hansen PA, Thomas VM, Ulrich CM, Kohli M, Chipman J, Swami U, Gupta S, Maughan BL, Agarwal N. Creatine supplementation and resistance training to preserve muscle mass and attenuate cancer progression (CREATINE-52): a protocol for a double-blind randomized controlled trial. BMC Cancer. 2024 Apr 18;24(1):493. doi: 10.1186/s12885-024-12260-3.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Adriana Coletta, PhD, MS, RD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing creatine monohydrate and Home-based, telehealth in people with Metastatic Prostate Cancer, run by University of Utah at 1 site in United States.
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 12 inclusion and 3 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 3 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Susan Sharry (801-585-3453, susan.sharry@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total lean mass (kg) as measured by whole-body dual energy x-ray absorptiometry (DXA) scan from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm (time frame: 52 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 NCT06112990, which also lists 1 linked publication.
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 3 Jun 2026.