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Dietary Supplement

Creatine + Resistance Training for Prostate Cancer (CREATINE-52 Trial)

Phase 3

Recruiting

Led By Adriana Coletta, PhD, MS, RD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject age ≥ 18 years old

Metastatic prostate cancer patients who have not met criteria for disease progression on current systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

CREATINE-52 Trial Summary

This trial tests if taking creatine and doing resistance training can help slow prostate cancer progression and improve physical function.

Who is the study for?

Men over 18 with metastatic prostate cancer not currently progressing on therapy can join. They must be undergoing hormone treatments, have internet access for video calls, and be willing to do a home-based exercise program and take creatine or placebo as assigned.Check my eligibility

What is being tested?

The trial is testing if creatine supplements combined with resistance training at home can help maintain muscle mass and slow down prostate cancer progression over a year-long period compared to a placebo group.See study design

What are the potential side effects?

Creatine supplementation may cause weight gain due to water retention, digestive issues like nausea or diarrhea, muscle cramping, and possibly affect kidney function in those with pre-existing conditions.

CREATINE-52 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My prostate cancer has spread, but my current treatment is still working.

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I can take care of myself but might not be able to do heavy physical work.

CREATINE-52 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in insulin sensitivity as measured by 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.

Change in markers of cancer progression as measured by changes in PSA and cfDNA from baseline to end-of-study (end of week 52) in the Cr+RT arm compared with the PLA+RT arm.

Change in physical function scores as measured by the 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.

+1 more

Other outcome measures

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.

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.

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.

+6 more

CREATINE-52 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1Experimental Treatment2 Interventions

Home-based, telehealth resistance training (RT) with creatine monohydrate supplementation (Cr)

Group II: Arm 2Placebo Group2 Interventions

Home-based, telehealth resistance training (RT) with placebo (PLA)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

creatine monohydrate

2010

Completed Phase 3

~450

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,778,701 Total Patients Enrolled

8 Trials studying Prostate Cancer

5,349 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,671 Previous Clinical Trials

40,926,569 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,650 Total Patients Enrolled

29 Trials studying Prostate Cancer

6,957 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Arm 1 been officially recognized by the FDA?

"The safety of Arm 1 receives a rating of 3, suggesting that there are numerous studies affirming its efficacy and the reliability of such evidence."

Answered by AI

Is this experiment open to new participants at present?

"The clinicaltrials.gov database reflects that this particular trial is not currently recruiting; however, it was last modified on October 30th 2023. Additionally, there are 199 other studies actively searching for patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression

2023. "Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112990.