Creatine plus resistance training to improve muscle loss after androgen-deprivation therapy for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial will enroll men on androgen-deprivation therapy and assign them to daily creatine monohydrate or a matched placebo while all participants complete a 12-week supervised resistance training program. Outcomes measured before and after the intervention include muscle density and architecture by ultrasound, body composition, muscle strength, functional performance tests, inflammatory biomarkers, and vascular function. The creatine and placebo are given once daily and exercise sessions occur three times per week under professional supervision. The study aims to determine whether adding creatine produces greater improvements in muscle health than resistance training alone.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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.

Where it's running

• School of Physical Education and Sport - USP
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Guilherme WP da Fonseca, PhD — School of Physical Education and Sport - USP
• Study coordinator: Guilherme WP da Fonseca, PhD
• Email: guilhermefonseca@usp.br
• Phone: +55 11 3091 2137

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sarcopenia in Patients After Cardiac Surgery

  This observational study tests how common sarcopenia is after cardiac surgery and whether current care helps improve muscle mass and function.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07908472

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer

  This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.

  Recruiting Niguarda Hospital · Milan, Lombardy · NCT07879820

• Bone marrow mesenchymal stem cell injection for sarcopenia

  This study tests whether CG-BM1, a stem cell injection, can be safely given to adults with sarcopenia to see if it helps improve muscle health.

  Recruiting Phase 1/2 GuangZhou Cellgenes Biotechnology Co., Ltd. · Guangzhou · NCT07865676

• Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer

  This study tests whether imaging, dose measurements, and blood tests can predict which men with metastatic castration-resistant prostate cancer will respond to Lu-177 PSMA therapy.

  Recruiting Lithuanian University of Health Sciences · Kaunas · NCT07863986

• Salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

  This observational study tests whether salvage HDR brachytherapy can help men with locally recurrent prostate cancer after initial radiotherapy, using advanced imaging and biopsy to guide treatment.

  Recruiting at 8 sites Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Benidorm, Alicante and 9 other locations · NCT07860528

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.