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New treatment option for Prostate Cancer
Official title Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy
ClinicalTrials.gov ID: NCT07463092
What this study is testing
- What it's testing
- 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.
- 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 40 and older, men only
You may be able to join if
- 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...
- Patients receiving continuous or intermittent androgen deprivation therapy;
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. 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.