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New treatment option for Metastatic Prostate Cancer
Official title Creatine Supplementation and Resistance Training to Preserve Muscle Mass and Attenuate Cancer Progression
ClinicalTrials.gov ID: NCT06112990
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Subject age ≥ 18 years old.
- Metastatic castration-sensitive prostate cancer patients who have not met criteria for disease progression (per Prostate Cancer Working Group...
- Currently treated with surgical castration or medical castration with Gonadotropin-releasing hormone (GnRH) agonists/antagonists, and/or an androgen...
- 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...
You likely can't join if
- Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
- Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2.
- ECOG Performance Status ≥ 3
See the full eligibility criteria
- 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...
- 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).
- 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...
- 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.
- Treatment with cytotoxic chemotherapy within 12 weeks prior to enrollment.
- Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73m2.
- ECOG Performance Status ≥ 3
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.