Phase 3 Prostate Cancer Trial, Recruiting NCT06112990 Sponsor: University of Utah Condition: Prostate Cancer
Back to Prostate Cancer

Phase 3 Prostate Cancer Trial, Recruiting

NCT06112990
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older.
  • People who have prostate cancer that has spread to other parts of the body (metastatic) and is still responding to hormone-lowering treatment, with no signs of the disease getting worse according to standard prostate cancer guidelines.
  • People currently being treated with surgical or medical hormone-lowering therapy (such as GnRH agonists or antagonists), and/or a newer type of hormone therapy (such as abiraterone, enzalutamide, apalutamide, or darolutamide), with that treatment having started at least 12 weeks before joining the trial.
  • People whose general physical functioning is rated at a level where they are able to care for themselves, even if they cannot do heavy physical work (confirm with trial site for exact rating).
  • People who are not currently doing structured resistance or strength training (such as set workout sessions) on two or more days per week.
  • People who have regular access to a device with internet and video call capability, such as a computer, smartphone, or tablet.
  • People who have an active MyChart account or are willing to create one for the purposes of the trial.
  • People who are willing to take part in a home-based strength exercise program two days per week.
  • People who are willing to take either a creatine monohydrate supplement or a placebo (dummy supplement) every day for the full 52 weeks of the trial, and to avoid taking any other creatine or nutritional supplements during that time.
  • People who are willing to fill out and submit a weekly supplement log to the study team throughout the 52-week trial.
  • People who are willing to attend three in-person assessment visits at the start, at 24 weeks, and at 52 weeks.
  • People who are able to give informed consent and sign an approved consent form.

Who may not be able to join:

  • People who have received cytotoxic chemotherapy (a strong cancer-killing drug treatment) within the 12 weeks before joining the trial.
  • People whose kidneys are not functioning well enough, based on a specific blood test result (confirm with trial site for the exact threshold).
  • People whose general physical functioning is at a level where they have limited ability to care for themselves (confirm with trial site for exact rating).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Adriana Coletta, PhD, MS, RD, Huntsman Cancer Institute/ University of Utah

Phone: 801-585-3453

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
9 November 2023
Est. completion
30 November 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov